Overview
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.
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.
Eligibility
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;
- KPS60
- No serious mental disorders ;
- Left ventricular ejection fraction 50%
- Sufficient hepatic function defined by ALT/AST3 x ULN and bilirubin2 x ULN;
- Sufficient renal function defined by creatinine clearance2 x ULN;
- Sufficient pulmonary function defined by indoor oxygen saturation92%;
- With single or venous blood collection standards, and no other cell collection contraindications;
- Ability and willingness to adhere to the study visit schedule and all protocol requirements.
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.