RecruitingPhase 1Phase 2NCT04271644
BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
Sponsor
Chongqing Precision Biotech Co., Ltd
Enrollment
80 participants
Start Date
Apr 1, 2019
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria16
- 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%;
- 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 CAR-T cells
BCMA CAR-T cell therapy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04271644
Related Trials
Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma
NCT0617988873 locations
A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
NCT0725851133 locations
Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma
NCT068761421 location
A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
NCT0709545225 locations
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
NCT0582851132 locations