A Phase 2 interventional study of MT-3724 and Gemcitabine in Non-hodgkin Lymphoma,B Cell, Refractory Diffuse Large B-Cell Lymphoma and Relapsed Diffuse Large B-Cell Lymphoma, sponsored by Molecular Templates, Inc.. Terminated at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-16.
Sponsored by Molecular Templates, Inc. · Phase 2, Interventional, and Treatment
Among 1,131 studies in Lymphoma, Large B-Cell, Diffuse with a site in United States — 126 open to participants now, 218 under way, 18 of them phase 3. Lymphoma, Large B-Cell, Diffuse · United States.
Among the 1,131 studies in Lymphoma, Large B-Cell, Diffuse with a site in United States, this one is the 825th largest by enrollment of the 963 interventional ones that give a count, is one of 39 that started in 2018, is one of 380 in phase 2, and was the 824th registered.
1,869 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 356 are open to participants now.
Browse Lymphoma, Large B-Cell, Diffuse studies →126 of the 1,131 studies in Lymphoma, Large B-Cell, Diffuse with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Nathan Denlinger · Sites in United States
Ages 18+
Roswell Park Cancer Institute · Sites in United States
Ages 18+
University of Michigan Rogel Cancer Center · Sites in United States
Ages 18+
Weill Medical College of Cornell University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 265 Lymphoma, Large B-Cell, Diffuse studies recruiting now, 177 (67%) set no upper age limit and 50 (19%) stop at 75 or younger; 25 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,131 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 542 · Phase 2 537 · Phase 3 82 · Phase 4 2
First in 1988; this study’s year is marked. 39 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 8 is below the median of 45 across 1,498 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Median enrollment 37 across the 963 interventional studies, 84 across the 66 observational. Of the 848 that completed or were terminated, 330 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
314 of 1,131 have an industry lead sponsor. The 10 most frequent:
Molecular Templates, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Molecular Templates, Inc. has 2 studies filed under Lymphoma, Large B-Cell, Diffuse — fewer than ten, so there is no comparison to draw.
71 of the studies in Lymphoma, Large B-Cell, Diffuse with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04442022Phase 3Karyopharm Therapeutics IncA Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma | 2026-12 |
| NCT01804686Phase 3Janssen Research & Development, LLCA Long-term Extension Study of PCI-32765 (Ibrutinib) | 2026-12-31 |
| NCT04529772Phase 3Acerta Pharma BVA Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) | 2027-02-22 |
| NCT04799275Phase 3National Cancer Institute (NCI)Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma | 2027-03-01 |
| NCT05578976Phase 3GenmabA Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) | 2027-06 |
Add all 71 to your calendar (.ics) → With an account.
Among the 1,131 studies in Lymphoma, Large B-Cell, Diffuse with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the safety and tolerability of MT-3724 in combination with gemcitabine and oxaliplatin (GEMOX) in participants with relapsed or refractory B-Cell NHL.
This is a multi-center, open-label two-part study evaluating the safety and tolerability of MT-3724 in combination with GEMOX in relapsed or refractory B-cell Lymphoma patients.
Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 in combination with standard treatment of GEMOX
Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 from Part 1 in the MTD Expansion Cohort, where MT-3724 will be given at the MTD in combination with GEMOX. In addition, the PK, PD, immunogenicity and tumor response at the MTD of MT-3724 in combination with GEMOX will be more thoroughly evaluated in Part 2.
In original protocol and amendment 2, participants will be administered intravenous (IV) MT-3724 over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be administered MT-3724 on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 will be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).
Continued Treatment with MT-3724 in combination with GEMOX will continue for four cycles of until death, disease progression, unacceptable toxicity, withdrawal of consent or another reason for withdrawal.
After four cycles, the participants who experience clinical benefit can continue MT-3724 treatment with additional cycles of 28 days each (either alone or in combination with GEMOX) if supported by the investigator's assessment of the benefit-risk ratio, after consultation with sponsor and Medical Monitor
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have B-cell NHL that, in the investigator's opinion, could benefit from MT-3724+GEMOX therapy. At least one documented relapse of NHL, by:
Have received all approved therapies for NHL that are applicable for the patient in the opinion of the treating physician.
Have by Lugano Classification for NHL
Have adequate bone marrow function, as determined by:
Have adequate kidney function, assessed by thecreatinine clearance () to be ≥ 50 mL/min either measured or estimated using the Cockcroft-Gault formula. .
a. At the investigator's discretion,calculated estimated CLcr of \< 50mL/min may be verified based on the 24-hour urine collection. Subjects with GFR ≥50 mL/min will be eligible irrespective of the estimated CLcr result.
Have adequate hepatic function, as determined by:
Have adequate coagulation, as determined by:
Have adequate serum albumin, as determined by:
a. Albumin ≥ 3.0 g/dL
Subjects of reproductive potential and their partners must agree to either to abstain continuously from heterosexual intercourse or to use a reliable method between signing the informed consent until 6 months following the last dose of MT-3724 or GEMOX . The investigator or a designated associate should advise the subject how to achieve adequate contraception. The following birth control methods may be considered as adequate
Exclusion criteria:
Received any amount of anti-CD20 MAb therapy within the following periods before the start of treatment
Received radiotherapy to tumor lesions that would be chosen as target lesions () within 4 weeks before the start of treatment, unless the lesion exhibited objective progression between the radiotherapy and the screening according to the Lugano Classification for NHL.
a. Palliative radiotherapy to non-target lesions is allowed at the investigator's discretion after consultation with the Medical Monitor and sponsor.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In original protocol and amendment 2, participants will be administered intravenous (IV) MT-3724 10 micrograms per kilograms (mcg/kg) over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg will be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).
Drug: MT-3724 · Drug: Gemcitabine · Drug: Oxaliplatin
In original protocol and amendment 2, participants will be planned to administer IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be planned to administer Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be planned to administer MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg will be planned to administer weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be planned to administer on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).
Drug: MT-3724 · Drug: Gemcitabine · Drug: Oxaliplatin
In original protocol and amendment 2, participants will be planned to administer IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be planned to administer Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be planned to administer MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg will be planned to administer weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be planned to administer on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).
Drug: MT-3724 · Drug: Gemcitabine · Drug: Oxaliplatin
Participants will be planned to administer Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Drug: MT-3724 · Drug: Gemcitabine · Drug: Oxaliplatin
MT-3724 will be administered.
Gemcitabine will be administered.
Oxaliplatin will be administered.
Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is any treatment-emergent adverse event (TEAE) that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s).
Time frame: Up to 168 Days
Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE is as any untoward medical occurrence in a participant or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental intervention(s). A SAE is any AE that is fatal or life-threatening, permanently disabling (incapacitating or interfering with the ability to resume usual life patterns), results in unplanned in-subject hospitalization or prolongation of an existing hospitalization, results in a congenital abnormality or birth defect, or any other situation that require medical or scientific judgement. Number of participants with common \>=0 percent (%) TEAEs and SAEs are presented.
Time frame: Up to 168 Days
Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724
Blood samples were planned to be collected at indicated time points for pharmacokinetic (PK) analysis of MT-3724. PK Population consisted of all participants who received at least one dose of MT-3724 and have at least one post-Baseline PK value.
Time frame: Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)
Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724
Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.
Time frame: Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)
Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724
Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.
Time frame: Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)
Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range
Blood samples were planned to be collected at indicated time points for analysis of immunophenotyping parameters which included cluster of differentiation (CD)3 (Percentage \[%\] and absolute), CD4 (% and absolute), CD8 (% and absolute), CD4:CD8 ratio, CD19 (% and absolute), Natural Killer (NK) cells (% and absolute), naïve B cells (% and absolute), non-switched memory B cells (% and absolute), class-switched memory B cells, Immunoglobulin (Ig)M only memory B cells (% and absolute), and total memory B cells (% and absolute).
Time frame: Up to 168 Days
Part 1 and 2: Number of Participants With Anti-drug Antibody Titer
Blood samples were planned to be collected at indicated time points for analysis of anti-drug antibody titer.
Time frame: Up to 168 Days
Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies
Blood samples were planned to be collected at indicated time points for analysis of positive neutralizing antibodies.
Time frame: Up to 168 Days
Part 1 and 2: Objective Response Rate
Objective response rate is defined as the participants with a reduction in tumor size (Partial Response \[PR\] or Complete Response \[CR\]) using the Lugano Classification for Lymphoma, adjusted according to Lymphoma response to immunomodulatory therapy criteria (LYRIC).
Time frame: Up to 168 Days
Part 1 and 2: Disease Control Rate
Disease Control rate is defined as participants with objective response of CR, PR or stable disease (SD) defined as SD for 3 months or longer from the Baseline scan.
Time frame: Up to 168 Days
Part 1 and 2: Duration of Response
Duration of Response is defined as the time from first documented stable disease to the actual date of disease progression or death, for participants who met the criteria of having stable disease for at least 3 months from Baseline. Data was not collected due to early termination of the trial.
Time frame: Up to 168 Days
Part 1 and 2: Progression-free Survival
Progression-Free Survival is defined as the time from the start of treatment with MT-3724 on Cycle 1 Day 1 to the date of disease progression or death from any cause. Data was not collected due to early termination of the trial.
Time frame: Up to 168 Days
This was a 2-part study \[Part 1 (Dose Escalation) and Part 2 (Dose Expansion)\], to investigate safety, tolerability, efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX) in participants with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma.
| Milestone | Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Started | 8 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 8 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 |
| Withdrew: Progressive disease | 4 | 0 | 0 | 0 |
| Withdrew: Protocol deviation | 1 | 0 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 1 | 0 | 0 | 0 |
| Milestone | Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
A DLT is any treatment-emergent adverse event (TEAE) that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s).
| Participants | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) | 2 | — | — | — |
An AE is as any untoward medical occurrence in a participant or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental intervention(s). A SAE is any AE that is fatal or life-threatening, permanently disabling (incapacitating or interfering with the ability to resume usual life patterns), results in unplanned in-subject hospitalization or prolongation of an existing hospitalization, results in a congenital abnormality or birth defect, or any other situation that require medical or scientific judgement. Number of participants with common \>=0 percent (%) TEAEs and SAEs are presented.
| Participants | Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| TEAEs | 8 | — | — | — |
| SAEs | 4 | — | — | — |
Blood samples were planned to be collected at indicated time points for pharmacokinetic (PK) analysis of MT-3724. PK Population consisted of all participants who received at least one dose of MT-3724 and have at least one post-Baseline PK value.
| Micrograms per milliliter | Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724 | NA ± NA | — | — | — |
Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.
| Hours*micrograms per milliliter | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724 | NA ± NA | — | — | — |
Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.
| Hours | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724 | NA (NA to NA) | — | — | — |
Blood samples were planned to be collected at indicated time points for analysis of immunophenotyping parameters which included cluster of differentiation (CD)3 (Percentage \[%\] and absolute), CD4 (% and absolute), CD8 (% and absolute), CD4:CD8 ratio, CD19 (% and absolute), Natural Killer (NK) cells (% and absolute), naïve B cells (% and absolute), non-switched memory B cells (% and absolute), class-switched memory B cells, Immunoglobulin (Ig)M only memory B cells (% and absolute), and total memory B cells (% and absolute).
| Participants | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range | NA | — | — | — |
Blood samples were planned to be collected at indicated time points for analysis of anti-drug antibody titer.
| Participants | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Number of Participants With Anti-drug Antibody Titer | NA | — | — | — |
Blood samples were planned to be collected at indicated time points for analysis of positive neutralizing antibodies.
| Participants | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies | NA | — | — | — |
Objective response rate is defined as the participants with a reduction in tumor size (Partial Response \[PR\] or Complete Response \[CR\]) using the Lugano Classification for Lymphoma, adjusted according to Lymphoma response to immunomodulatory therapy criteria (LYRIC).
| Participants | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Objective Response Rate | 3 | — | — | — |
Disease Control rate is defined as participants with objective response of CR, PR or stable disease (SD) defined as SD for 3 months or longer from the Baseline scan.
| Participants | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Disease Control Rate | NA | — | — | — |
Duration of Response is defined as the time from first documented stable disease to the actual date of disease progression or death, for participants who met the criteria of having stable disease for at least 3 months from Baseline. Data was not collected due to early termination of the trial.
| Months | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Duration of Response | NA (NA to NA) | — | — | — |
Progression-Free Survival is defined as the time from the start of treatment with MT-3724 on Cycle 1 Day 1 to the date of disease progression or death from any cause. Data was not collected due to early termination of the trial.
| Months | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Part 1 and 2: Progression-free Survival | NA (NA to NA) | — | — | — |
Collected over All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 0/8 (0%) | 4/8 (50%) | 8/8 (100%) |
| Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | — | — | — |
| Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | — | — | — |
| Part 2: MT-3724/ GEM/ OX | — | — | — |
| Event | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| Capillary leak syndromeVascular disorders | 2/8 | — | — | — |
| Atrial flutterCardiac disorders | 1/8 | — | — | — |
| Chemotherapy induced neurotoxicityNervous system disorders | 1/8 | — | — | — |
| Event | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 7/8 | — | — | — |
| DysgeusiaNervous system disorders | 5/8 | — | — | — |
| Peripheral sensory neuropathyNervous system disorders | 5/8 | — | — | — |
| FatigueGeneral disorders | 5/8 | — | — | — |
| Oedema peripheralGeneral disorders | 4/8 | — | — | — |
| AnaemiaBlood and lymphatic system disorders | 4/8 | — | — | — |
| HyponatraemiaMetabolism and nutrition disorders | 4/8 | — | — | — |
| Neutrophil count decreasedInvestigations | 4/8 | — | — | — |
| Platelet count decreasedInvestigations | 4/8 | — | — | — |
| DiarrheaGastrointestinal disorders | 3/8 | — | — | — |
Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.
| Age, Continuous(Years) | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX | Total |
|---|---|---|---|---|---|
| Mean | 70.8 ± 7.42 | — | — | — | 70.8 ± 7.42 |
| Sex: Female, Male(Participants) | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX | Total |
|---|---|---|---|---|---|
| Female | 1 | — | — | — | 1 |
| Male | 7 | — | — | — | 7 |
| Race/Ethnicity, Customized(Participants) | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Part 2: MT-3724/ GEM/ OX | Total |
|---|---|---|---|---|---|
| Black or African American | 1 | — | — | — | 1 |
| White | 6 | — | — | — | 6 |
| Unknown | 1 | — | — | — | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2018 to primary completion in Mar 2021, 30 months.
Results were first posted in Aug 2022, 1 year 5 months after primary completion.
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Studies of the drug tested here: MT-3724
Lymphoma, Large B-Cell, Diffuse →
Molecular Templates, Inc.