Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Received Three or More Lines of Therapy
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2023-11-13
10
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
G
Guangzhou Bio-gene Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D Chimeric antigen receptor (CAR) T-cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Received Three or More Lines of Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legal guardian voluntarily consents to participate
- Age between 18 and 75 years
- Diagnosed with multiple myeloma according to international standards
- Measurable disease by serum or urine M-protein levels or light-chain criteria
- Relapsed or refractory after at least three prior therapies including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody
- Diagnosed with relapsed/refractory or primary refractory disease
- Last treatment ineffective or disease progressed within 60 days after last therapy
- Toxicity from last therapy recovered to less than grade 2 by CTCAE criteria
- ECOG performance status of 1 or 2 and expected survival of at least 3 months
- Liver, kidney, and heart function within specified limits including bilirubin, ALT, AST, creatinine, hemoglobin, oxygen saturation, calcium levels, and left ventricular ejection fraction
- No significant pleural effusion
- Able to establish venous access and no contraindications for apheresis
You will not qualify if you...
- Diagnosis or treatment of other cancers within the past 3 years
- Prior anti-tumor therapies before apheresis including targeted therapies, epigenetic drugs, clinical trial drugs or devices, monoclonal antibodies, cytotoxic agents, proteasome inhibitors, immunomodulatory drugs, or radiotherapy
- Involvement of the central nervous system
- Diagnosis of Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis
- Positive for certain infections including hepatitis B, hepatitis C, HIV, CMV, or EBV above detection limits
- Severe allergy history
- Severe systemic diseases or poor heart, liver, or kidney function
- Graft versus host disease within 6 months before screening or requiring immunosuppressive treatment
- Active autoimmune or inflammatory nervous system diseases
- Oncology emergencies needing treatment before screening or infusion
- Uncontrolled infections needing antibiotics
- Recent exposure to hematopoietic growth factors or immunosuppressive agents before apheresis
- Recent major surgery or planned surgery during the study
- Recent live attenuated vaccination
- Severe mental illness
- Addiction to alcohol or drugs
- Pregnant or breastfeeding women or those planning pregnancy within two years after CAR-T infusion
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
H
Heng Mei
CONTACT
C
Chenggong Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here