Actively Recruiting
Practical Clinical Study of Dual-targeting BCMA-GPRC5D CAR-T Cell Therapy for Extramedullary Infiltration in Refractory/Relapsed Multiple Myeloma
Led by Beijing GoBroad Hospital · Updated on 2025-11-26
18
Participants Needed
1
Research Sites
4 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
Researchers are evaluating the safety of a dual-targeting BCMA and GPRC5D CAR-T cell therapy for patients with relapsed or refractory multiple myeloma who have extramedullary infiltration. This phase 1, multicenter, open-label, non-randomized, single-arm trial aims to assess dose-limiting toxicity and adverse events within one month after reinfusion of the CAR-T cells. The study expects to recruit up to 18 participants. Participants receive a lymphodepletion treatment with fludarabine and cyclophosphamide about 3 to 5 days before the CAR-T cell infusion. The dual-targeting BCMA-GPRC5D CAR-T cells are then infused 48 hours after completing chemotherapy. This single treatment approach focuses on targeting the cancer cells expressing BCMA and GPRC5D. During the study, participants will be monitored for dose-limiting toxicities and any adverse events occurring within 30 days after the CAR-T cell infusion. Researchers will also assess overall remission rates at 90 days and track event-free survival, duration of response, and overall survival for up to two years after enrollment. This thorough follow-up includes clinical evaluations and safety monitoring to understand the therapy's impact over time.
CONDITIONS
Brief 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...
- Voluntarily participate in the trial and have good compliance.
- Aged between 18 and 75 years old, regardless of gender.
- Diagnosed with relapsed or refractory multiple myeloma with measurable extramedullary lesions.
- Positive for BCMA and GPRC5D in tumor cells by flow cytometry or immunohistochemistry.
- Cardiac function with left ventricular ejection fraction > 50%.
- Liver function with ALT and AST less than 3 times the upper limit of normal.
- Renal function with creatinine clearance rate ≥ 40 mL/min.
- Coagulation function with PT and APPT less than 1.5 times the upper limit of normal.
- Arterial oxygen saturation (SpO2) > 95%.
- Pulmonary function with FEV1% predicted value ≥ 50%.
- Female patients of childbearing age must have a negative pregnancy test before treatment.
- Male patients must be willing to use effective contraception for 1 year after treatment.
- ECOG performance status score ≤ 2.
- Expected survival time greater than 3 months.
You will not qualify if you...
- Pregnant or lactating women.
- Active infections not effectively controlled.
- Active autoimmune diseases not effectively controlled.
- Adverse reactions from previous treatments not recovered to CTCAE grade ≤ 1.
- Active graft-versus-host disease not effectively controlled in allogeneic transplant patients.
- Positive tests for HBV, HCV, syphilis, or HIV infection.
- Allergic or intolerant to fludarabine or cyclophosphamide.
- Known symptomatic non-plasma cell infiltrative central nervous system diseases.
- Uncontrollable cardiovascular or cerebrovascular diseases within 6 months.
- History of other untreated malignancies within the past 5 years.
- Unable or unwilling to comply with study requirements.
- Previous use of a CAR-T vector with the same structure.
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.
Duration - 3 to 5 days
Participants receive lymphodepletion chemotherapy with fludarabine and cyclophosphamide approximately 3 to 5 days before CAR-T cell infusion.
Duration - Up to 2 years
Participants receive dual-targeting BCMA-GPRC5D CAR-T cell infusion 48 hours after completion of lymphodepletion chemotherapy.
Trial Site Locations
Total: 1 location
1
Shanghai Liquan Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yao Yao
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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