Finding studies
Finding studies
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Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
Lead
Medical College of Wisconsin
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
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
