Actively Recruiting
Dual-target BCMA-GPRC5D CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration
Led by Beijing GoBroad Hospital · Updated on 2025-11-26
18
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
S
Shanghai Liquan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - GPRC5D CAR-T cell therapy. The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and GPRC5D CAR - T cell therapy for extramedullary infiltration in relapsed/refractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the reinfusion of BCMA-GPRC5D CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the reinfusion. It is expected that no more than 18 participants will be recruited.
CONDITIONS
Official Title
Dual-target BCMA-GPRC5D CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers who agree to participate and can follow the study requirements
- Aged between 18 and 75 years, any gender
- Diagnosed with relapsed or refractory multiple myeloma with measurable extramedullary lesions
- Positive for BCMA and GPRC5D in bone marrow, cerebrospinal fluid, or tumor tissue tests
- Cardiac function with left ventricular ejection fraction above 50% within past 2 weeks
- Liver enzymes (ALT and AST) less than 3 times the upper limit of normal
- Kidney function with creatinine clearance rate of at least 40 mL/min
- Coagulation tests (PT and APPT) less than 1.5 times the upper limit of normal
- Arterial oxygen saturation above 95%
- Pulmonary function with FEV1% predicted value of at least 50%
- Female participants of childbearing age must have a negative pregnancy test before treatment
- Male participants must agree to use effective contraception for 1 year after treatment
- Eastern Cooperative Oncology Group (ECOG) score of 2 or less
- Expected survival time longer than 3 months
You will not qualify if you...
- Pregnant or breastfeeding women
- Active infections not effectively controlled
- Active autoimmune diseases not effectively controlled
- Unresolved adverse reactions from previous treatments worse than grade 1
- Active graft-versus-host disease after allogeneic transplant not effectively controlled
- Positive tests for HBV DNA, hepatitis C antibody with RNA above detectable limits, syphilis antibody, or HIV antibody
- Allergy or intolerance to fludarabine or cyclophosphamide
- Known symptomatic central nervous system diseases not caused by plasma cell infiltration
- Uncontrolled severe heart or brain blood vessel diseases within 6 months, including severe heart failure, recent heart attack, serious arrhythmias, or severe cardiomyopathy
- History of untreated or concurrent other cancers within past 5 years
- Unable or unwilling to comply with study procedures
- Previous use of CAR-T therapy with the same structure as this trial's treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Liquan Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yao Yao
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