NCT04186520

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

Phase I/II Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.

Detailed description

This is a Phase 1/Phase 2 study. The objectives are as follows: 1. Phase 1: Determine the safety of a fixed dose of 2.5x10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15 in relapsed refractory B-cell NHL with flexible 8/12-day manufacturing and a fixed 12-day manufacturing process along with an evaluation in chronic lymphocytic leukemia (CLL) and central nervous system (CNS) lymphoma. 2. Phase 1b: Four arms: Arm A: 8/12 flexible manufacturing arm. Determine safety, efficacy, and feasibility of flexible manufacturing. Arm B: Fixed 12-day manufacturing arm. Determine safety and efficacy of fixed CAR manufacturing. Arm C: 8/12 flexible manufacturing with mandated cryopreservation prior to infusion of LV20.19 CAR T-cells. Determine the impact of cryopreservation on safety or efficacy of LV20.19 CAR T-cells. Arm D: 8/12 flexible manufacturing expansion cohort in CLL. Determine safety and efficacy in CLL. Arm E: 8/12 flexible manufacturing cohort in central nervous system (CNS) lymphoma. 3. Phase 2 1. Determine the 3-month CR rate of CAR-20/19-T cells in MCL 2. Determine the feasibility of a flexible manufacturing process of CAR-20/19-T cells from patient apheresis products using the CliniMACS Prodigy Cell processing device

Conditions

• Non Hodgkin Lymphoma (NHL)
• Mantle Cell Lymphoma (MCL)
• Chronic Lymphocytic Leukemia (CLL)
• Follicular Lymphoma
• Marginal Zone Lymphoma
• Diffuse Large B Cell Lymphoma
• Primary Mediastinal Large B-cell Lymphoma (PMBCL)
• Central Nervous System Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	8/12-Day Production of Car-T Cells	A fixed dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.
BIOLOGICAL	8/12-Day Production of Cryopreserved Car-T Cells	A fixed cryopreserved dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.
BIOLOGICAL	12-Day Production of Car-T Cells	A fixed dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

Timeline

• Start date: 2020-05-18
• Primary completion: 2027-02-28
• Completion: 2029-02-28
• First posted: 2019-12-04
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study