NCT05094206

CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies

Phase I Trial of Anti-CD20, Anti-CD19, Anti-CD22 CAR (CAR20.19.22) T-cells for Relapsed, Refractory B-cell Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this phase I study, the investigators will first evaluate the safety of CAR20.19.22 T-cells in patients with B-cell non-Hodgkin lymphoma (NHL) / chronic lymphocytic leukemia (CLL).

Detailed description

This is a phase I, interventional, open label, dose-finding treatment study designed to evaluate the safety and efficacy CAR20.19.22 T-cells in adult patients with B-cell malignancies that have failed prior therapies.

Conditions

• B-cell Non Hodgkin Lymphoma
• B-cell Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	0.75x10^6 cells/kg CAR20.19.22 cells	Dose escalation: CAR20.19.22 cells will be administered at one of three 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 four doses: 0.75x10\^6 cells/kg, 1x10\^6 cells/kg, 2.5x10\^6 cells/kg or 5x10\^6.
BIOLOGICAL	1x10^6 cells/kg CAR20.19.22 cells	CAR20.19.22 cells will be administered at one of four 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 four doses: 0.75x10\^6 cells/kg, 1x10\^6 cells/kg, 2.5x10\^6 cells/kg or 5x10\^6.
BIOLOGICAL	2.5x10^6 cells/kg CAR20.19.22 cells	CAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection. The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10\^6 cells/kg, 1x10\^6 cells/kg, 2.5x10\^6 cells/kg or 5x10\^6.
BIOLOGICAL	5x10^6 cells/kg CAR20.19.22 cells	CAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection. The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10\^6 cells/kg, 1x10\^6 cells/kg, 2.5x10\^6 cells/kg or 5x10\^6.
BIOLOGICAL	Dose expansion: The maximum tolerated dose of CAR20.19.22 cells	Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10\^6 cells/kg, 1x10\^6 cells/kg, 2.5x10\^6 cells/kg or 5x10\^6 cells/kg.

Timeline

• Start date: 2022-06-30
• Primary completion: 2024-01-29
• Completion: 2024-01-29
• First posted: 2021-10-26
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study