AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas
NCT06340737 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 148
Last updated 2025-08-07
Summary
This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed / refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion.
Conditions
- Follicular Lymphoma
- Mantle Cell Lymphoma
- Hairy Cell Leukemia
- Lymphoplasmacytic Lymphoma
- Burkitt Lymphoma
- Marginal Zone Lymphoma
- Waldenstrom Macroglobulinemia
- Large B-cell Lymphoma
Interventions
- DRUG
-
CD22CART Infusion
Dosing and Administration Participants will be hospitalized to receive treatment with CD22CART, if not previously hospitalized, and will remain hospitalized for approximately 5 to 7 (±2) days. Patients may be discharged once all AEs have resolved to Grade 1 or better, or at the discretion of the treating physician. Participants may be discharged with non critical and clinically stable or slowly improving toxicities (e.g., renal insufficiency, cytopenias) even if \> Grade 1, if deemed appropriate by the investigator.
Sponsors & Collaborators
-
The Leukemia and Lymphoma Society
collaborator OTHER - lead OTHER
Principal Investigators
-
Matthew Frank, MD, PhD · Stanford University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-29
- Primary Completion
- 2031-04-30
- Completion
- 2031-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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