NCT04049383

CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL

Phase 1 Study of Redirected Autologous T Cells Engineered to Contain an Anti-CD19 and Anti-CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed/ Refractory CD19 or CD20 B-cell Acute Lymphoblastic Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.

Detailed description

This is a phase 1, interventional, open label, treatment study designed to evaluate the safety and feasibility of infusion of CAR-20/19-T in subjects with B cell ALL who have relapsed after prior therapies or refractory disease and are not candidates for curative intent standard therapy. There will be two phases of this study. First, a dose escalation phase will determine the safe CAR-20/19-T cell dose in patients B-cell ALL. Once the desired dose has been identified there will be a six-patient dose expansion phase at the specified dose level.

Conditions

• Acute Lymphoblastic Leukemia, in Relapse
• Acute Lymphoblastic Leukemia With Failed Remission
• Acute Lymphoblastic Leukemia Recurrent
• Acute Lymphoblastic Leukemia Not Having Achieved Remission
• Acute Lymphoblastic Leukemia, Pediatric
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg)	The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. Dose Level -1: 5 x 10\^5 CAR-20/19-T cells/kg
BIOLOGICAL	CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg)	The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. Dose Level 0: 1 x10\^6 CAR-20/19-T cells/kg (starting dose level)
BIOLOGICAL	CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)	The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. Dose Level 1: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose)
BIOLOGICAL	CAR-20/19-T cells	The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. The dose expansion dose level is still to be determined and this section will be updated.

Timeline

• Start date: 2020-10-16
• Primary completion: 2025-06-01
• Completion: 2025-09-01
• First posted: 2019-08-08
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study