CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL
- Conditions
- CD19+ Relapse/Refractory B-ALL
- Interventions
- Biological: CAR-T-19 Cells
- Registration Number
- NCT05270772
- Lead Sponsor
- Chinese PLA General Hospital
- Brief Summary
This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.
- Detailed Description
B-cell acute lymphoblastic leukemia (B-ALL) accounting for 85% of all ALL cases, is a common hematological malignancy in children and adults. CD19 is a widely expressed antigen in both normal B cells and B cells-derived leukemia and lymphomas. This is a single-arm, open-label phase I study of CAR-T-19 (anti CD19 scFv chimeric antigen receptor T) cells for patients with CD19-positive relapse/refractory B-ALL under the age of 25.
Primary endpoint is to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19. Secondary endpoints measure ORR, OS and others.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9
- Patients with relapse/refractory B-ALL.
- Tumor cells from bone marrow or peripheral blood are measured CD19+ with 3 months before enrollment.
- Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
- Patients who have a life expectancy of at least 12 weeks.
- Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures.
- Patients with extramedullary relapse (EMR).
- Patients with genetic diseases, Burkitt lymphoma and leukemia or other malignancies.
- Patients positive for any of the following: HbsAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA.
- Patients with other uncontrolled infection.
- Patients who received anti-CD19 / anti-CD3 therapy, or any other anti-CD19 therapy.
- Patients with active Grade II-IV GVHD within 3 months prior to screening.
- Tumor cells are detected in cerebrospinal fluid.
- Patients who received HSCT within 3 months prior to screening.
- Anticipated other clinical trials within 4 weeks before this trial
- Pregnant or lactating women.
- Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CAR-T-19 Cells CAR-T-19 Cells The patients with CD19+ relapse or refractory B-ALL will receive a single infusion of autologous CAR-T-19 cells, with the escalated dose ranging from 0.5×10\^6/kg to 5.0×10\^6/kg CAR+ cells.
- Primary Outcome Measures
Name Time Method Dose limiting toxicity (DLT) up to 2 years DLT within 28 days (±3 days) after CAR-T-19 infusion.
Maximum tolerated dose (MTD) up to 2 years The maximum dose of DLT occurred in ≤1/6 of the subjects within 28 days (±3 days) after CAR-T-19 infusion.
Adverse events up to 2 years Percentage of subjects with adverse events.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) up to 2 years The time from CAR-T-19 infusion to death from any cause.
Overall recovery rate (ORR) up to 2 years Percentage of subjects who achieved complete response (CR) and incomplete hematologic recovery (CRi) for the first time at Day 28 and Day 90 after CAR-T-19 infusion.
MRD-Negative Rate up to 2 years Percentage of subjects with MRD-negative CR and incomplete blood and MRD-negative CRi for the first time at Day 28 and Day 90 after CAR-T-19 infusion.
Duration of Response (DOR) up to 2 years The time from achieving CR and CRi for the first time to recurrence or death from any cause
Progression-free Survival (PFS) up to 2 years The time from CAR-T-19 infusion to recurrence, progression or death from any cause, whichever occurs first.
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China