Actively Recruiting
A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Led by Chunrui Li · Updated on 2025-06-11
18
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
Sponsors
C
Chunrui Li
Lead Sponsor
N
Nanjing IASO Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-center, open-label, dose-exploration study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or plasma cell leukemia.
CONDITIONS
Official Title
A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- At least 3 prior therapies including chemotherapy with proteasome inhibitors and immunomodulatory agents
- Disease is relapsed, progressive, or refractory multiple myeloma or plasma cell leukemia
- Evidence of GPRC5D expression on tumor cells by immunohistochemistry or flow cytometry
- Measurable disease: 3 10% plasma cells in bone marrow or M-protein 3 0.5 g/dL serum or 200 mg/24 hr urine, or abnormal serum free light chain levels
- For extramedullary myeloma, lesions 3 2 cm if no other evaluable lesions
- ECOG performance status 0 to 2
- Estimated life expectancy 3 12 weeks
- Adequate organ function including specified blood counts, liver enzymes, kidney function, coagulation, oxygen saturation, and heart function
- Agreement to use effective contraception for one year from consent to CAR T infusion
- Signed informed consent form
You will not qualify if you...
- Known graft-versus-host disease or need for long-term immunosuppressive therapy
- Recent anti-cancer treatments within specified timeframes before leukapheresis including monoclonal antibodies, cytotoxic therapy, proteasome inhibitors, immunomodulatory agents, or other anti-tumor therapies
- Use of therapeutic dose corticosteroids (>20 mg prednisone or equivalent) within 7 days before screening, except physiological, inhaled, or topical use
- Uncontrolled hypertension
- Serious heart disease including unstable angina, recent myocardial infarction, severe heart failure, or severe arrhythmias
- Unstable systemic diseases requiring medical treatment
- Second cancers within 5 years except certain successfully treated local cancers
- History of organ transplantation
- Major surgery within 2 weeks before leukapheresis or planned surgery during or shortly after study
- Participation in another interventional clinical study within 1 month before consent
- Uncontrolled active infection requiring systemic therapy within 7 days before leukapheresis
- Positive tests for hepatitis B, hepatitis C, HIV, cytomegalovirus, or syphilis
- Pregnant or breastfeeding women
- Mental illness, consciousness disorder, or central nervous system disease
- Other conditions deemed inappropriate by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
C
Chunrui Li
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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