Actively Recruiting
BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma: A Prospective, Single-center, Single-arm Phase I/IIa Clinical Trial
Led by Shenzhen University General Hospital · Updated on 2024-10-16
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multiple myeloma is a blood cancer where abnormal plasma cells grow in the bone marrow, mostly affecting middle-aged and older adults. This condition remains generally incurable, with most patients experiencing disease relapse or progression. The trial focuses on patients with relapsed or refractory multiple myeloma, particularly those who have shown limited response or relapse after existing targeted therapies, and aims to evaluate a new dual-target CAR-T cell therapy. The study tests a treatment using BCMA-GPRC5D CAR-T cells, which are designed to target specific proteins found on multiple myeloma cells. Participants receive a dose ranging from 2 to 5 million CAR-T cells per kilogram of body weight. This is a single-arm, single-center trial where all participants undergo this investigational therapy to assess its safety and effectiveness. Participants will be closely monitored from the start of treatment through at least 30 days afterward for adverse events. Clinical responses will be tracked for up to two years to evaluate treatment effects. Various tests, including blood and bone marrow assessments, will be performed to measure disease changes. The trial includes safety evaluations, disease response monitoring, and requires participants to meet specific health criteria to join and continue in the study.
CONDITIONS
Brief 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, any gender
- Voluntary participation with signed informed consent
- Diagnosed with relapsed or refractory multiple myeloma after chemotherapy including bortezomib or lenalidomide with ineffective treatment or progression within 60 days
- At least one measurable multiple myeloma lesion meeting specific laboratory or imaging criteria
- Myeloma cells positive for BCMA and GPRC5D expression 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 of 0 to 2
- No contraindications to peripheral blood apheresis
- Expected survival of at least 12 weeks
- Female participants of childbearing potential must have a negative pregnancy test within 7 days prior to therapy and not be lactating
- Effective contraception must be used by all participants of childbearing potential throughout the study
You will not qualify if you...
- History of allergies to components of the cell therapy products
- Laboratory abnormalities including high bilirubin, elevated liver enzymes, high creatinine, low hemoglobin, low neutrophil count without growth factor support, or low platelet count without transfusion
- Severe heart failure (NYHA class III or IV) or left ventricular ejection fraction below 50%
- Abnormal lung function with oxygen saturation below 92%
- Recent serious heart events within 12 months
- Uncontrolled grade 3 hypertension
- Prolonged QT interval or severe arrhythmias
- History of severe neurological disorders like head injury, epilepsy, or stroke
- Need for anticoagulants other than aspirin
- Urgent treatment need due to tumor progression or spinal cord compression
- CNS metastasis or involvement symptoms
- Serious complications or diseases increasing risk or affecting study participation
- Prior allogeneic stem cell transplantation
- Plasma cell leukemia
- Use of prednisone over 5 mg/day or equivalent corticosteroids before apheresis and within 2 weeks before CAR-T infusion
- Autoimmune diseases or immunodeficiency requiring immunosuppressive therapy
- Uncontrolled active infections
- Live vaccination within 4 weeks before enrollment
- Infection with HIV, HBV, HCV, or syphilis; HBV carriers
- History of alcoholism, drug abuse, or mental illness
- Participation in other clinical research within 3 months
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From initial treatment to 30 days after treatment
Participants receive BCMA-GPRC5D CAR-T cell therapy targeting relapsed or refractory multiple myeloma.
1 treatment visit and multiple visits for safety monitoring up to 30 days post-treatment
Duration - Up to 2 years after treatment
Participants are monitored for disease-related clinical responses and long-term safety for up to 2 years after treatment.
Regular follow-up visits scheduled during the 2-year period
Trial Site Locations
Total: 1 location
1
Shenzhen University General Hospital
Shenzhen, Guangdong, China
Actively Recruiting
Research Team
X
Xiao Guo, Doctor
L
LiXin Wang, Doctor
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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