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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed written willing to sign a consent form; 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

BCMA targeted prime CAR-T cells

BCMA targeted prime CAR-T cell therapy

Locations (1)

920th Hospital of Joint Logistics Support Force
Kunming, Yunnan, China