Actively Recruiting
A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Led by Nanjing IASO Biotechnology Co., Ltd. · Updated on 2025-05-20
12
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
Sponsors
N
Nanjing IASO Biotechnology Co., Ltd.
Lead Sponsor
R
Ruijin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-center, open-label, dose-escalation 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
- Have had at least 3 prior lines of therapy including proteasome inhibitors and immunomodulatory agents
- Disease is relapsed, progressed, or refractory multiple myeloma or plasma cell leukemia
- Evidence of GPRC5D expression on tumor cells by immunohistochemistry or flow cytometry
- Measurable disease by bone marrow or protein levels as defined in study criteria
- ECOG performance status 0 to 2
- Estimated life expectancy of at least 12 weeks
- Adequate organ function including specified blood counts, liver enzymes, kidney function, coagulation, oxygen saturation, and heart function
- Agree to use effective contraception for one year from consent to CAR T-cell infusion
- Signed informed consent form
You will not qualify if you...
- Known graft-versus-host disease or needing long-term immunosuppressive therapy
- Recent anti-cancer treatments within specific timeframes before leukapheresis
- High dose corticosteroid use within 7 days prior to screening, except certain exceptions
- Uncontrolled hypertension
- Serious heart conditions including recent heart attack, unstable angina, severe heart failure, or severe arrhythmias
- Unstable systemic diseases requiring treatment
- Second malignancies within 5 years except certain treated cancers
- History of organ transplantation
- Major surgery within 2 weeks before leukapheresis or planned during study
- Participation in another interventional clinical trial within 1 month before consent
- Active uncontrolled infections requiring systemic therapy
- Positive tests for certain viral infections including hepatitis B, hepatitis C, HIV, CMV, or syphilis
- Pregnant or breastfeeding women
- Mental illness, consciousness disorders, or central nervous system disease
- Other conditions judged 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
Ruijin Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
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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