Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Chongqing Precision Biotech Co., Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The response rate of BCMA CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA CAR-T cells therapy
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
Detailed Description
There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed written informed consent
- •Diagnose as relapsed /refractory multiple myeloma, and meet one of the following conditions:
- •Failed to standard chemotherapy regimens;
- •Relapse after complete remission, high-risk and / or refractory patients ;
- •Relapse after hematopoietic stem cell transplantation;
- •Evidence for cell membrane BCMA expression；
- •All genders, ages: 18 to 75 years；
- •The expect time of survive is above 12 weeks;
- •No serious mental disorders ;
- •Left ventricular ejection fraction ≥50%
Exclusion Criteria
- •Have received CAR-T therapy or other genetically modified cell therapy before screening；
- •Participated in other clinical research within 1 month before screening；
- •Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;
- •Live attenuated vaccine within 4 weeks before screening;
- •Convulsion or stoke within past 6 months;
- •Previous history of other malignancy;
- •Presence of uncontrolled active infection;
- •Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;
- •Pregnant or breasting-feeding women;
- •Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.
Outcomes
Primary Outcomes
The response rate of BCMA CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA CAR-T cells therapy
Time Frame: 6 months
The response rate of BCMA CAR-T treatment will be recorded and assessed according to the IMWG
Adverse events that related to treatment
Time Frame: 2 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Secondary Outcomes
- Levels of IL-6 in Serum(3 months)
- Rate of BCMA CAR-T cells in bone marrow and peripheral blood(2 years)
- Progress-free survival(PFS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma(2 years)
- Quantity of BCMA CAR copies in bone marrow and peripheral blood(2 years)
- Duration of Response (DOR) of BCMA CAR-T treatment in patients with refractory/relapsed Multiple Myeloma(2 years)
- Overall survival(OS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma(2 years)
- Quantity of clonal plasma cells in bone marrow(1 years)