Tests BCMA-targeted CAR-T cell therapy for relapsed or refractory multiple myeloma
Tests BCMA-targeted CAR-T cells in adults with relapsed or refractory multiple myeloma.
Plain-language title generated from the registry record
Registry title: a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
Key facts
- Where
- Kunming, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT04776330, who can take part
Where in China
- 920th Hospital of Joint Logistics Support ForceKunming, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chongqing Precision Biotech Co., Ltd
- Trial code
- NCT04776330
- Record updated
- 25 February 2025
- Original description
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.Read full original descriptionShow less
Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
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.
Inclusion: 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: The patients treatment by inhibitor of T cell; Previous history of other malignancy; Presence of uncontrolled active infection; Evidence of disorder that need the treatment by glucocorticoids; 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; Active or chronic GVHD; Pregnant or breasting-feeding women.