CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory Multiple Myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.Dual Specificity CD38 and BCMA CAR-T cells can recognize and kill the malignant cells through recognition of CD38 or BCMA. This is a phase 1/2 study designed to determine the safety of dual specificity CD38 and BCMA CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory Multiple Myeloma.
1. PRIMARY OBJECTIVES: 1. To evaluate the feasibility and safety of dual specificity CD38 and BCMA CAR-T cells in patients with relapsed or refractory Multiple Myeloma. 2. To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells.Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD38 and BCMA CAR-T cells over time. 2. SECONDARY OBJECTIVES: 1.For patients with detectable disease, measure anti-tumor response due to dual specificity CD38 and BCMA CAR-T cell infusions. 2.The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using Day 0: 1-5x10e6/kg total dose on day 0.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
1\) Biological: Dual Specificity CD38 and BCMA CAR-T Cells,2)1-5X10E6/Kg
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, China
RECRUITINGNumber of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability
Time frame: 24weeks
MTD of dual specificity CD38 and BCMA CAR-T cells
The highest dose of dual specificity CD38 and BCMA CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of dual specificity CD38 and BCMA CAR-T cells
Time frame: 4 weeks
Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes
Time frame: 24 weeks
Six-month Objective response rate of complete remission and partial remission
Time frame: 24 weeks
Six-month Overall survival
Time frame: 24 weeks
Six-month Progression free survival
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.