RecruitingPhase 1Phase 2NCT04776330
a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
Sponsor
Chongqing Precision Biotech Co., Ltd
Enrollment
80 participants
Start Date
Mar 7, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria15
- Signed written informed consent;
- Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, 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 3 months;
- KPS\>60
- No serious mental disorders ;
- Left ventricular ejection fraction ≥50%
- Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
- Sufficient renal function defined by creatinine clearance≤2 x ULN;
- Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. 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 Criteria7
- Previous history of other malignancy;
- Presence of uncontrolled active infection;
- Evidence of disorder that need the treatment by glucocorticoids;
- Active or chronic GVHD
- The patients treatment by inhibitor of T cell
- Pregnant or breasting-feeding women;
- 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.
Interventions
BIOLOGICALBCMA targeted prime CAR-T cells
BCMA targeted prime CAR-T cell therapy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04776330
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