A Phase 1 interventional study of CD19-Targeted In Vivo CAR-T Injection (first infusion, Day 0); CD22 -Targeted In Vivo CAR-T Injection (second infusion, Day 7) in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia, In Vivo CAR-T and B-Cell Acute Lymphoblastic Leukemia, sponsored by Liping Dou. Recruiting at 1 site in China. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Liping Dou · Phase 1, Interventional, and Treatment
This is a single-center, open-label, single-arm, prospective, investigator-initiated dose-escalation study to evaluate the safety, tolerability, preliminary efficacy, and cellular kinetics of an in vivo CAR-T cell immunotherapy targeting CD19 sequentially followed by CD22, in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). The investigational product is a targeted lentiviral vector that transduces the patient's endogenous T/NK cells in situ; no leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is required. Participants receive an intravenous infusion of CD19-targeted in vivo CAR-T on Day 0, followed by an intravenous infusion of CD22-targeted in vivo CAR-T on Day 7. Before the Day 7 infusion, the investigator will assess each participant to determine whether the second infusion should proceed, based on: (i) the proportion of CAR-positive T/NK cells in peripheral blood, which reflects the success of in vivo transduction and early expansion after the first infusion; (ii) the maximum grade and current control of adverse events occurring after the first infusion, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS); and (iii) the participant's general condition, including Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function (cardiac, hepatic, renal, pulmonary, and coagulation). The second infusion will be postponed or cancelled if any of these assessments indicates that the risk outweighs the benefit, for example grade >=3 CRS or grade >=2 ICANS that has not resolved to grade \<=1, or investigator-judged deterioration in organ function. Dose escalation follows a traditional 3+3 design with planned dose levels of 1×10\^9, 3×10\^9, and 6×10\^9 transducing units (TU), guided by dose-limiting toxicities (DLTs) assessed during Days 0-28; higher dose levels may be explored if the maximum tolerated dose is not reached. Treatment-emergent adverse events and serious adverse events, including CRS, immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, and organ toxicity, will be assessed. Preliminary antitumor activity will be evaluated by objective response rate (ORR), overall survival (OS), and progression-free survival (PFS), and the expansion and persistence of in vivo-generated CAR-T cells in peripheral blood will also be evaluated.
This is a single-center, single-arm, open-label, prospective, investigator-initiated clinical study of CD19 sequential CD22 in vivo CAR-T cell immunotherapy in adults with R/R B-ALL whose tumor cells express CD19 and CD22. The investigational product is an engineered lentiviral vector in which the receptor-binding domain of the viral envelope has been mutated to abolish its native pantropic infectivity, and a targeting module composed of an anti-CD7 nanobody (VHH) and a T/NK-cell-specific ligand (CD58 extracellular domain) has been incorporated into the envelope, enabling specific transduction of circulating T cells and NK cells in situ and expression of a CAR directed against CD19 (first infusion) or CD22 (second infusion); no leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is required. Treatment consists of an intravenous infusion of CD19-targeted in vivo CAR-T on Day 0 and an intravenous infusion of CD22-targeted in vivo CAR-T on Day 7. Before the second infusion, the investigator will assess each participant to determine whether the second infusion should proceed, based on: (i) the proportion of CAR-positive T/NK cells in peripheral blood, used to evaluate the efficiency of in vivo transduction and early expansion after the first infusion; (ii) the maximum grade, current grade, and response to management of CRS, ICANS, and other adverse events occurring after the first infusion; and (iii) general condition, including ECOG performance status, vital organ function (cardiac, hepatic, renal, pulmonary, and coagulation), and infection status. Participants who meet the criteria for continued dosing will receive the second infusion as planned. The second infusion will be postponed if grade >=3 CRS or grade >=2 ICANS occurs and does not resolve to grade \<=1, or if the investigator judges that continued dosing carries a risk exceeding the potential benefit; if the participant does not recover to a state permitting dosing within the prespecified window, the second infusion will be cancelled and the participant will continue protocol-specified safety follow-up and efficacy assessment. Three dose levels are planned (1×10\^9, 3×10\^9, and 6×10\^9 TU) using a traditional 3+3 escalation design, and the DLT observation window is Days 0-28 after treatment; upon completion of DLT observation at the highest planned dose level without reaching the maximum tolerated dose (MTD), the investigator may explore higher dose levels based on accumulated safety and pharmacodynamic data. Planned enrollment is 12 participants. The study includes a screening period (within 28 days), a treatment period, and a follow-up period of up to 24 months. Safety assessments include adverse events and serious adverse events graded per NCI CTCAE v5.0, with CRS and ICANS graded per the ASTCT consensus criteria; hematologic toxicity, infection, organ toxicity, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), tumor lysis syndrome (TLS), and viral shedding (peripheral blood, saliva, and urine) are also monitored. Disease response is assessed by bone marrow morphology and multiparameter flow cytometry (CR and CRi), with measurable residual disease (MRD) assessed in bone marrow and cerebrospinal fluid. Exploratory cellular kinetics include peripheral blood CAR transgene copies (qPCR) and CAR-positive cell counts, with sampling planned on Days 2, 4, 6, 8, 10, 12, 14, 17, 21, 24, and 28 and at Months 2, 3, 6, 9, and 12 after infusion, and derivation of peak expansion (Cmax), time to peak (Tmax), and the area under the curve from Day 0 to Day 28 (AUC0-28d). Because the investigational product is an integrating lentiviral vector, participants will be enrolled in a long-term safety follow-up program for the detection of delayed adverse events, in accordance with the applicable guidance on gene therapy products; the duration, schedule, and responsible parties are specified in the protocol.
976 studies on the registry are indexed under Burkitt Lymphoma; 159 are open to participants now.
This study's planned enrollment of 12 is below the median of 36 across 765 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Liping Dou is the lead sponsor of 13 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Relapse within 6 months after first remission; Primary refractory disease: failure to achieve complete remission after 2 cycles of standard chemotherapy; Failure to achieve complete remission or relapse after one or more lines of salvage chemotherapy; Relapse after hematopoietic stem cell transplantation.
(estimated by the Cockcroft-Gault formula) ≥60 mL/min or serum creatinine ≤1.5 × the (ULN); Serum (ALT) and aspartate aminotransferase (AST)≤2.5×upper limit of normal (ULN), total ≤1.5×ULN; Cardiac ≥50%, no pericardial effusion on echocardiography, and no significant abnormalities on (ECG); No pleural effusion, and oxygen saturation >92% on room air at baseline.
Exclusion Criteria:
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.
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 study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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 share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and 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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
In Vivo CAR-T Treatment Group - sequential intravenous infusion of CD19-targeted in vivo CAR-T on Day 0, followed by CD22-targeted in vivo CAR-T on Day 7, at one of three planned dose levels (1×10\^9, 3×10\^9, or 6×10\^9 TU) assigned by a traditional 3+3 dose-escalation design; no leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is administered. Before the second infusion, the investigator must assess (i) the proportion of CAR-positive T/NK cells in peripheral blood, (ii) the maximum grade and current control of CRS, ICANS, and other adverse events after the first infusion, and (iii) ECOG performance status and vital organ function, in order to determine whether the second infusion should proceed as planned; the second infusion will be postponed or cancelled in participants with grade \>=3 CRS or grade \>=2 ICANS that has not resolved to grade \<=1. Higher dose levels may be explored if the maximum tolerated dose is not reached.
Drug: CD19-Targeted In Vivo CAR-T Injection (first infusion, Day 0); CD22 -Targeted In Vivo CAR-T Injection (second infusion, Day 7)
The investigational products are engineered lentiviral vector-based in vivo gene therapy products. The viral envelope receptor-binding domain has been mutated to abolish native pantropic infectivity, and a targeting module composed of an anti-CD7 nanobody (VHH) and a T/NK-cell-specific ligand (CD58 extracellular domain) has been incorporated into the envelope, enabling specific transduction of circulating T cells and NK cells in situ and expression of a chimeric antigen receptor directed against CD19 (first infusion, Day 0) or CD22 (second infusion, Day 7). No leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is required. Dose escalation follows a traditional 3+3 design with planned dose levels of 1×10\^9, 3×10\^9, and 6×10\^9 transducing units (TU), guided by the occurrence of dose-limiting toxicities (DLTs).
Also known as: In vivo CD19/CD22 CAR-T; targeted lentiviral vector for in vivo CAR-T generation
Safety and Tolerability
DLTs, the number and percentage of participants who experience DLT during the protocol-defined DLT observation period (Days 0-28) after the first in vivo CAR-T infusion.
Time frame: From the first in vivo CAR-T infusion through 12 months after treatment
Adverse Events
AEs are graded per NCI CTCAE v5.0
Time frame: From the first in vivo CAR-T infusion through 12 months after treatment
Cytokine Release Syndrome
Cytokine release syndrome (CRS) is graded according to the ASTCT consensus criteria.
Time frame: From the first in vivo CAR-T infusion through 12 months after treatment
Immune Effector Cell-associated Neurotoxicity Syndrome
immune effector cell-associated neurotoxicity syndrome (ICANS) is graded according to the ASTCT consensus criteria.
Time frame: From the first in vivo CAR-T infusion through 12 months after treatment
Objective Response Rate at Prespecified Follow-up Time Points
The objective response rate (ORR) at 1, 2, 3, 6, 9, 12, 18, and 24 months after treatment, defined as the proportion of participants who achieve a complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or complete remission with incomplete platelet recovery (CRp). The ORR at 3 months after treatment is the key evaluation time point.
Time frame: From the first in vivo CAR-T infusion through 24 months after treatment
Overall Survival
Overall survival (OS), defined as the time from the first in vivo CAR-T infusion to death from any cause. Participants who are alive at the last follow-up will be censored on the date of their last known survival status.
Time frame: From the first in vivo CAR-T infusion through 24 months after treatment
Progression-Free Survival
Progression-free survival (PFS), defined as the time from the first in vivo CAR-T infusion to the first documentation of objective disease progression or death from any cause, whichever occurs first.
Time frame: From the first in vivo CAR-T infusion through 24 months after treatment
Event-Free Survival
Event-free survival (EFS), defined as the time from the first in vivo CAR-T infusion to the first documentation of objective disease progression, relapse, or death from any cause, whichever occurs first.
Time frame: From the first in vivo CAR-T infusion through 24 months after treatment
Measurable Residual Disease (MRD) Negativity Rate
The proportion of participants with MRD negativity in bone marrow assessed by multiparameter flow cytometry among participants who achieve CR/CRi, at each prespecified assessment time point.
Time frame: At Day 28 and Months 2, 3, 6, 9, 12, 18, and 24 after the first in vivo CAR-T infusion
Cellular Kinetics (Pharmacokinetics) of In Vivo-Generated CAR-T Cells (Exploratory)
CAR transgene copy number in peripheral blood (qPCR), peak expansion of CAR-T cells in peripheral blood (Cmax).
Time frame: Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion
Time to Peak Expansion
Peripheral blood sampling is planned on Days 2, 4, 6, 8, 10, 12, 14, 17, 21, 24, and 28 and at Months 2, 3, 6, 9, and 12 after infusion.
Time frame: Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion
Area Under The Curve From Day 0 to Day 28
The area under the curve from Day 0 to Day 28 (AUC0-28d).Peripheral blood sampling is planned on Days 2, 4, 6, 8, 10, 12, 14, 17, 21, 24, and 28 and at Months 2, 3, 6, 9, and 12 after infusion.
Time frame: Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Aug 2028, 23 months after the start.
Of 87 non-industry phase 1 interventional studies under Burkitt Lymphoma, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 90. This study's planned 23 months is below that.
Counting every sponsor, half of 109 studies reached it within 61 months; a quarter within 38 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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