BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Launched by CHONGQING PRECISION BIOTECH CO., LTD · Feb 14, 2020

Keywords

ClinConnect Summary

**Summary of the Clinical Trial: BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma**

This clinical trial is testing a new treatment called BCMA-targeted CAR-T cell therapy for people with multiple myeloma who have not responded to other treatments. Multiple myeloma is a type of cancer that affects plasma cells in the blood. This study is specifically looking for patients whose cancer has either come back after treatment or has not improved with standard therapies. To participate, patients should be between 18 and 75 years old and must have a certain level of health, including good heart, liver, and kidney function.

If you or a loved one is interested in joining this study, you will need to sign an informed consent form, which means you understand what the trial involves. Participants will receive the BCMA-targeted CAR-T cell therapy and will be closely monitored for how well the treatment works and any side effects. The trial is currently recruiting participants, so there's an opportunity to contribute to important research that could help improve treatment options for multiple myeloma in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed written informed consent;
• 2. Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:
• • 1. Failed to standard chemotherapy regimens;
• • 2. Relapse after complete remission, high-risk and / or refractory patients ;
• • 3. Relapse after hematopoietic stem cell transplantation;
• • 3. Evidence for cell membrane BCMA expression；
• • 4. All genders, ages: 18 to 75 years；
• • 5. The expect time of survive is above 3 months;
• • 6. KPS\>60；
• • 7. No serious mental disorders ;
• • 8. Left ventricular ejection fraction ≥50%
• • 9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
• • 10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
• • 11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
• • 12. With single or venous blood collection standards, and no other cell collection contraindications;
• • 13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.
• Exclusion Criteria:
• • 1. Previous history of other malignancy;
• • 2. Presence of uncontrolled active infection;
• • 3. Evidence of disorder that need the treatment by glucocorticoids;
• • 4. Active or chronic GVHD；
• • 5. The patients treatment by inhibitor of T cell；
• • 6. Pregnant or breasting-feeding women;
• • 7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.