Medical College of Wisconsin
This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.
The purpose of this study is to determine the safety of fully human lentiviral 20.19 (h20.19) CAR T cells in patients with relapsed, refractory B-cell malignancies. A maximum of 12 patients will be treated in the Phase 1 cohort followed by a 12-patient expansion cohort (approximately 21 to 24 patients total).
General Inclusion Criteria for All Patients 1. Patients must be aged ≥ 18 years and ≤80 years with relapsed or refractory B-cell malignancy. 2. Absolute CD3 count ≥50 mm\^3. 3. Magnetic resonance imaging (MRI) brain and lumbar puncture with cerebral spinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with: 1. A history of CNS involvement OR 2. A clinical suspicion at the time of enrollment. 4. Karnofsky performance score ≥70. 5. Adequate hepatic function, defined as aspartate aminotransferase (AST), al…
Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.
Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.
Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10\^6 cells/kg or 2.5 X 10\^6 cells/kg.
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