CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- B Cell Lymphoma
- Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 30 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: Determine the feasibility of manufacturing CD22 CAR T cells for administration to children and young adults with relapsed/refractory (R/R) CD22 expressing B-cell ALL or lymphoma using the Miltenyi CliniMACS Prodigy system. Determine the safety of an established dose of CD22-CAR T ...
PRIMARY OBJECTIVE: Determine the feasibility of manufacturing CD22 CAR T cells for administration to children and young adults with relapsed/refractory (R/R) CD22 expressing B-cell ALL or lymphoma using the Miltenyi CliniMACS Prodigy system. Determine the safety of an established dose of CD22-CAR T cells in children and young adults with R/R CD22 expressing B-cell malignancies. SECONDARY OBJECTIVE: - Assess the clinical activity of CD22-CAR T cells in children and young adults with R/R CD22 expressing B-cell malignancies, including overall survival (OS) and progression free survival (PFS).
Tracking Information
- NCT #
- NCT04088864
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Liora Schultz, MD Stanford University
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