Study Summary
This is a phase 1/1b, interventional single arm, open label, treatment study designed to evaluate the safety and feasibility of infusion of autologous T cells engineered to contain an anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) single chain variable fragment (scFv) coupled to cluster of differentiation CD3ζ (CD3ζ) and co-stimulatory domain 4-1BB (4-1BB) signaling domains in patients with relapsed and/or refractory CD19 or CD20 positive B cell malignancies
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Request More InfoInterventions
CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg)BIOLOGICAL
CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 0: 2.5 x10\^5 CAR-20/19-T cells/kg (starting dose level)
CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg)BIOLOGICAL
CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 1: 7.5 x10\^5 CAR-20/19-T cells/kg
CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg)BIOLOGICAL
CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 2: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose)
Phase 1b Expansion Dose Level: 2.5 x 10\^6 cells/kg (single infusion)
CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)BIOLOGICAL
CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Froedtert Hospital & Medical College of Wisconsin | Milwaukee | Wisconsin | United States |