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Phase I/II Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies

2019-12-10 01:20:57 | BioPortfolio

Summary

This is a Phase I/II, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of IL-7/IL-15 manufactured 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 1/1b: Determine the safety of a fixed dose of 2.5 x 106 CAR-20/19-T cells/kg expanded with IL-7/IL-15 at 8 and 12-day manufacturing times in relapsed refractory B-cell NHL followed by expansion cohorts.

2. Phase 2:

1. Determine the three-month complete response (CR) rate of CAR-20/19-T cells in Mantle Cell Lymphoma.

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 Design

Conditions

Non Hodgkin Lymphoma

Intervention

8-Day Production of Car-T Cells, 12-Day Production of Car-T Cells

Status

Not yet recruiting

Source

Medical College of Wisconsin

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-10T01:20:57-0500

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