Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT04186520
Brief 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
Study:
NCT04186520
Study Brief:
Protocol Section:
NCT04186520