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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04186520
Other study ID # PRO00037171
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 18, 2020
Est. completion date January 2025

Study information

Verified date June 2024
Source Medical College of Wisconsin
Contact Medical College of Wisconsin Cancer Center Clinical Trials Offic
Phone 866-680-0505
Email cccto@mcw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


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Study Design


Intervention

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.
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.
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.

Locations

Country Name City State
United States Medical College of Wisconsin and Froedtert Hospital Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Events after CAR 20/19-T cell infusion Incidence of adverse events using NCI CTCAE version 5.0. Within the first 28 days after infusion
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