CART22 Alone or in Combination With huCART19 for ALL
NCT03620058 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2025-10-14
Summary
This is a single center, open-label, phase 1 study to determine the safety and feasibility of infusing CART22-65s with or without huCART19 after administration of lymphodepleting chemotherapy in adult patients with relapsed or refractory B-ALL.
Conditions
- Chemotherapy Resistant Acute Lymphoblastic Leukemia
- Refractory Acute Lymphoblastic Leukemia
Interventions
- BIOLOGICAL
-
CART22-65s cells
Autologous T cells transduced with a lentiviral vector to express anti-CD22 scFv TCRz:41BB
- BIOLOGICAL
-
huCART19 Cells
Autologous T cells transduced with lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Noelle Frey, MD · University of Pennsylvania
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-27
- Primary Completion
- 2036-01-31
- Completion
- 2036-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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