Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies
NCT06408194 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-02-10
Summary
The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.
Conditions
Interventions
- DRUG
-
CD22CART infusion
CD22CART will be administered after Standard of Care (SOC) administration of tisagenlecleucel.
- DRUG
-
Tisagenlecleucel
All enrolled participants will receive lymphodepletion followed by standard of care tisagenlecleucel infusion.
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-13
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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