a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Launched by CHONGQING PRECISION BIOTECH CO., LTD · Feb 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BCMA-targeted prime CAR-T cell therapy for patients with relapsed or refractory multiple myeloma. Multiple myeloma is a type of blood cancer that can return or not respond to standard treatments. The trial aims to assess how effective and safe this new therapy is for patients who have already tried other treatments without success.

To be eligible for this trial, participants must be between 18 and 75 years old, have a confirmed diagnosis of relapsed or refractory multiple myeloma, and show evidence of a specific protein called BCMA on their cancer cells. They should also be in good overall health, with certain functioning organs, and must be able to commit to the study visits. If you join the trial, you will receive this new therapy and be closely monitored for any side effects or improvements in your condition. It’s important to discuss all your options with your doctor to see if this trial might be a good fit for you.

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.