A Phase 1/2 interventional study of MT-2111 in Diffuse Large B-Cell Lymphoma, sponsored by Tanabe Pharma Corporation. Active, not recruiting at 23 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Tanabe Pharma Corporation · Phase 1/2, Interventional, and Treatment
Among 16 studies testing loncastuximab tesirine in Lymphoma, Large B-Cell, Diffuse — 4 open to participants now, 6 under way, 1 of them phase 3. loncastuximab tesirine · Lymphoma, Large B-Cell, Diffuse.
Among the 16 studies testing loncastuximab tesirine in Lymphoma, Large B-Cell, Diffuse, this one is the 7th largest by enrollment, is one of 5 that started in 2023, is one of 2 in phase 1/2, and was the 11th registered.
1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.
This study's enrollment of 46 is close to the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →4 of the 16 studies testing loncastuximab tesirine in Lymphoma, Large B-Cell, Diffuse are open now, in 3 countries. Each count lists the studies.
loncastuximab tesirine: first FDA approval 2021 (ZYNLONTA), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
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 →16 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 5 started in 2023.
Median enrollment 39 across the 16 interventional studies. Of the 7 that completed or were terminated, 5 (71%) have results posted.
9 of 16 have an industry lead sponsor. The 9 most frequent:
Tanabe Pharma Corporation is the lead sponsor of 92 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Tanabe Pharma Corporation has 1 study filed under Lymphoma, Large B-Cell, Diffuse — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 16 studies testing loncastuximab tesirine in Lymphoma, Large B-Cell, Diffuse, from their registry updates:
[Phase I part] To investigate the safety, tolerability, and pharmacokinetics of MT-2111 monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In addition, the dose to be used in the Phase II part will be confirmed.
[Phase II part] To evaluate the efficacy of MT-2111 monotherapy in patients with relapsed/refractory DLBCL. In addition, the safety and pharmacokinetics will be investigated.
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.
Exclusion Criteria:
Patients complicated with other active or patients with a history of other malignancies within 3 years before . However, the following are exceptional:
Patients positive for HBs antigen, HBc antibody, or HBs antibody. However, patients who meet any of the following are eligible:
Patients who received anticancer therapy during the following periods prior to the start of study drug administration (Cycle 1 Day 1).
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
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.
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.
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.
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.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
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.
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.
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.
Drug: MT-2111
i.v. infusion
Also known as: Loncastuximab tesirine
Overall response rate (ORR) by independent central review
Time frame: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)
Duration of response (DOR)
Time frame: The time from the date of first observation of complete response (CR) or partial response (PR) until progressive disease (PD) or death in patients with CR or PR observed (Up to 48 months)
Complete response rate (CRR)
Time frame: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)
Overall survival (OS)
Time frame: The time from the date of first dose until death regardless of the occurrence of intercurrent event (Up to 48 months)
Progression-free survival (PFS)
Time frame: The time from the date of first dose until PD or death (Up to 48 months)
Relapse-free survival (RFS)
Time frame: The time from the date of first observation of CR until PD or death in patients with CR observed (Up to 48 months)
Adverse events and adverse drug reactions
Time frame: From the start of premedication until 15 weeks after the last dose of the study drug or until the start of new anticancer therapy, whichever comes first.
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome.
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Body weight
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram (heart rate)
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram [RR, PR, QRS, QT (QTcF)]
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram (presence or absence of abnormal findings)
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Serum drug concentration
\[Phase 1 part\] Cycle 1 \[each cycle is 3 weeks (21 days) in duration\]: Day 1, 2, 5, 8 and 15, Cycle 2: Day 1, 2, 8 and 15, Cycle 3: Day 1 and 8, odd number Cycle: Day 1,end of treatment (EOT)\*, and 15 weeks after the last dose \[Phase 2 part\] Cycle 1 and 2: Day 1, 8 and 15, odd number Cycle : Day 1, EOT\*, and 15 weeks after the last dose \*: After the decision to discontinue treatment with study drug and prior to the start of any new anticancer therapy, the scheduled evaluations will be performed preferably 30 days after the last dose of study drug.（Up to 13 months after the first treatment）
Time frame: Cycle 1 (each cycle is 3 weeks): Days 1, 2*, 5*, 8, and 15. Cycle 2: Days 1, 2*, 8, and 15. Cycle 3: Days 1 and 8*. Odd numbered Cycles: Day 1. End of treatment (up to 13 months after first dose), 15 weeks after the last dose. *Phase 1 only.
Anti-drug antibodies (including neutralizing antibodies)
\[Phase 1 part\] Cycle 1 \[each cycle is 3 weeks (21 days) in duration\]: Day 1 and 15, Cycle 2: Day 1, odd number Cycle: Day 1, end of treatment (EOT)\*, and 15 weeks after the last dose \[Phase 2 part\] Cycle 1: Day 1 and 15, Cycle 2: Day 1, odd number Cycle : Day 1, EOT\*, and 15 weeks after the last dose \*: After the decision to discontinue treatment with study drug and prior to the start of any new anticancer therapy, the scheduled evaluations will be performed preferably 30 days after the last dose of study drug.（Up to 13 months after the first treatment）
Time frame: Cycle 1 (each cycle is 3 weeks): Days 1 and 15. Cycle 2: Day 1. Odd numbered cycles: Day 1. End of Treatment (up to 13 months after first dose) and 15 weeks after the last dose.
Plan to share: Yes — When requested by a qualified researcher in the field of science or medicine, Tanabe Pharma Corporation will share clinical trial data that was collected from individual patients in a clinical trial with that researcher after a review committee of experts determines that such sharing is appropriate. Access Criteria: Please refer to the following link for conditions and limitations for sharing data. URL: https://www.tanabe-pharma.com/en/develop/protocol.html
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Loncastuximab tesirine
Lymphoma, Large B-Cell, Diffuse →