Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04186520
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2019-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies
Sponsor:
Medical College of Wisconsin
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: