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ACTIVE NOT RECRUITING
NCT03070327
PHASE1

BCMA Targeted CAR T Cells With or Without Lenalidomide for the Treatment of Multiple Myeloma

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2017-02-27

Completion Date

2027-02

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

BIOLOGICAL

EGFRt/BCMA-41BBz CAR T cell

Modified T cell infusions will be administered 2-7 days following the completion of conditioning chemotherapy.There are 3 planned dose levels for this study: 1x10\^6, 3x10\^6, and 1x10\^7 EGFRt/BCMA-41BBz CAR T cells/kg, and a dose -1 level at 3x10\^5 EGFRt/BCMA-41BBz CAR T cells/kg, if needed; each dose cohort will consist of 3-6 patients.

DRUG

Cyclophosphamide

Cyclophosphamide 3000 mg/m2 IV once on day -7 to -2 or low intensity cy/flu (cyclophosphamide 300 mg/m2/day x 3 + fludarabine 30 mg/m2/day x 3) with the last day occurring on day -7 to -2 are the default options for is the default conditioning chemotherapy.

DRUG

Lenalidomide.

A cohort of patients will be treated with CAR T cell therapy and concomitant Lenalidomide. 10mg PO 21/28 days will be started no less then 1 week prior to clinical apheresis.

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States