B Cell Maturation Antigen Targeted CAR-T Cells in Treatment With Relapsed and Refractory Multiple Myeloma
NCT05150522 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2021-12-09
Summary
For the treatment of relapsed and refractory MM, the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma pointed out that relapsed MM is highly heterogeneous, and individualized evaluation of relapsed patients is required to determine the treatment time. Patients with biochemical recurrence with only elevated M protein do not need immediate treatment, only regular follow-up visits. For patients with CRAB manifestations or rapid biochemical relapse, treatment needs to be initiated immediately. Patients who relapse within 6 months can switch to a drug combination with other mechanisms of action; patients who relapse within 6 to 12 months should first switch to a drug combination with other mechanisms of action, or they can be retreated with the original drug; 12 months Patients with the above recurrence can use the original regimen to re-induction therapy, or switch to a drug regimen with other mechanisms of action. Bortezomib, lenalidomide, and thalidomide are currently the key drugs for the treatment of relapsed MM in China. Patients with suitable conditions should undergo autologous hematopoietic stem cell transplantation, while allogeneic hematopoietic stem cell transplantation is rarely used because of higher transplant-related mortality.
Conditions
- Multiple Myeloma
- Relapse Multiple Myeloma
- Refractory Multiple Myeloma
Interventions
- BIOLOGICAL
-
BCMA CAR-T cells
BCMA CAR-T cells infusion
Sponsors & Collaborators
-
Shenzhen University General Hospital
lead OTHER
Principal Investigators
-
Li Yu · Shenzhen University General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-01
- Primary Completion
- 2024-07-31
- Completion
- 2024-07-31
Countries
- China
Study Locations
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