BCMA Targeted CAR T Cells With or Without Lenalidomide for the Treatment of Multiple Myeloma
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.
|Multiple Myeloma||Biological: EGFRt/BCMA-41BBz CAR T cell Drug: Cyclophosphamide Drug: Lenalidomide.||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Intervention Model Description:
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.Masking: None (Open Label)
Primary Purpose: Treatment
|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)|
- MTD of gene-modified T cells [ Time Frame: 36 months ]The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level. T cell dose may be divided in up to three infusions administered over up to 7 days.
|Actual Study Start Date:||February 27, 2017|
|Estimated Study Completion Date:||February 2020|
|Estimated Primary Completion Date:||February 2020 (Final data collection date for primary outcome measure)|
|Experimental: BCMA Targeted CAR T Cells with or without Lenalidomide||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03070327
|Contact: Claudia Diamonte||(212) 639-5317||DiamontC@mskcc.org|
|Contact: Craig Sauter, MD||212-639-3460|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Sham Mailankody, MD 212-639-2131|
|Contact: Craig Sauter, MD 212-639-3460|
|Principal Investigator: Sham Mailankody, MD|
|Principal Investigator:||Sham Mailankody, MD||Memorial Sloan Kettering Cancer Center|