Actively Recruiting
BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma
Led by Shenzhen University General Hospital · Updated on 2024-10-16
10
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
At present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse after receiving targeted BCMA CAR T-cell therapy, and there is a problem of target escape. The specific high expression of GPRC5D in multiple myeloma cells makes it possible to combine BCMA and GPRC5D in the treatment of MM. This study aims to investigate the safety and efficacy of BCMA-GPRC5D CAR-T therapy in the treatment of relapsed or refractory MM.
CONDITIONS
Official Title
BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Voluntary participation with signed informed consent
- Diagnosed with relapsed or refractory multiple myeloma
- Prior treatment with bortezomib or lenalidomide chemotherapy with ineffective outcome or progression within 60 days
- Presence of one or more measurable multiple myeloma lesions meeting specified laboratory or clinical criteria
- Positive BCMA and GPRC5D expression on myeloma cells confirmed by flow cytometry or immunohistochemistry
- No salvage chemotherapy within 4 weeks before cell therapy
- No antibody drug therapy within 2 weeks before cell therapy
- ECOG performance status 0-2
- No contraindications to peripheral blood apheresis
- Expected survival of at least 12 weeks
- Female participants of childbearing potential must have negative pregnancy test within 7 days before cell therapy and not be breastfeeding; both female and male participants of childbearing potential must use effective contraception throughout the study
You will not qualify if you...
- History of allergies to any ingredients in the cell products
- Abnormal laboratory test results including elevated bilirubin, liver enzymes, creatinine, low hemoglobin, neutrophils, or platelets
- Severe cardiac conditions including NYHA class III or IV heart failure or LVEF <50%
- Abnormal lung function with blood oxygen saturation <92%
- Recent serious heart events within 12 months
- Uncontrolled grade 3 hypertension
- Prolonged QT interval or severe arrhythmia
- History of significant neurological disorders
- Use of anticoagulants other than aspirin
- Urgent treatment needed due to tumor progression or spinal cord compression
- Presence of CNS metastasis or involvement
- Serious complications or diseases increasing risk or affecting study participation
- History of allogeneic hematopoietic stem cell transplantation
- Plasma cell leukemia
- Use of prednisone >5 mg/day or equivalent corticosteroids within 2 weeks before CAR-T infusion
- Autoimmune diseases or immunodeficiencies requiring immunosuppressive therapy
- Active uncontrolled infection
- Live vaccination within 4 weeks before enrollment
- Infection with HIV, HBV, HCV, or positive TPPA/RPR; HBV carriers
- History of alcoholism, drug abuse, or mental illness
- Participation in other clinical trials within 3 months
- Any other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shenzhen University General Hospital
Shenzhen, Guangdong, China
Actively Recruiting
Research Team
X
Xiao Guo, Doctor
CONTACT
L
LiXin Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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