NCT03070327: Phase 1 - BCMA Targeted CAR T Cells With or Without Lenalidomide for Multiple Myeloma
Updated: Jun 15, 2022
A Phase I Trial of B-cell Maturation Antigen (BCMA) Targeted EGFRt/BCMA-41BBz Chimeric Antigen Receptor (CAR) Modified T Cells With or Without Lenalidomide for the Treatment of Multiple Myeloma (MM)
The purpose of this phase I clinical trial is to test the safety of these CAR T cells in patients with myeloma.
There are two parts of this study. Part 1 of the study consists of screening for BCMA, Lenalidomide assignment and cell collection. Part 2 of the study is treatment with modified CAR T cells.
This is an open-label, dose escalating, nonrandomized, single-center, phase I study of EGFRt/BCMA-41BBz CAR T cells in patients with a diagnosis of MM. Dose escalation will follow a standard 3-by-3 escalation design. Cohorts of 3-6 patients will be infused with escalating doses of EGFRt/BCMA-41BBz CAR T cells to establish the maximum tolerated dose (MTD). After a dose level has been determined safe to escalate (DLT in 0/3 or 1/6 patients), a parallel cohort at that dose level will be conducted while patients are taking Lenalidomide.
Memorial Sloan Kettering Cancer Center
Juno Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03070327
Official Title: A Phase I Trial of B-cell Maturation Antigen (BCMA) Targeted EGFRt/BCMA-41BBz Chimeric Antigen Receptor (CAR) Modified T Cells With or Without Lenalidomide for the Treatment of Multiple Myeloma (MM)
First Posted : March 3, 2017
Click here for details on ClinicalTrials.gov
EGFRt/BCMA-41BBz CAR T cell
Blood Adv; 2020 Aug
Hematopoietic recovery in patients receiving chimeric antigen receptor T-cell therapy for hematologic malignancies
- New York: Memorial Sloan-Kettering Cancer Center New York
United States, New York