CAR2219 CAR-T Cells for the Treatment of R/R B Cell Leukemia and Lymphoma
NCT06834529 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-02-19
Summary
This is a single arm study to evaluate the safety and efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19/CD22 positive B cell Leukemia and Lymphoma.
Conditions
- Relapsed or Refractory B Cell Leukemia and Lymphoma
Interventions
- GENETIC
-
CAR2219-T cells
Genetic: CAR2219-T cells Each subject will be infused with single dose of CD2219-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 5×10\^5 /kg, the medium dose is 1×10\^6 /kg, and the high dose is 2×10\^6 /kg. Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells.
Sponsors & Collaborators
-
Affiliated Hospital to Academy of Military Medical Sciences
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 14 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-20
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
Countries
- China
Study Locations
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