BCMA Targeted CAR T Cells With or Without Lenalidomide for the Treatment of Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03070327|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : December 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: EGFRt/BCMA-41BBz CAR T cell Drug: Cyclophosphamide Drug: Lenalidomide.||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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)|
|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)|
|Actual Study Start Date :||February 27, 2017|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
|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.
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.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070327
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Sham Mailankody, MD||Memorial Sloan Kettering Cancer Center|