The fully human anti-GPRC5D CAR T-cell therapy RD118 induces durable remissions in relapsed/refractory multiple myeloma.
Mengmeng Pan, Di Wang, Jie Xu...
https://pubmed.ncbi.nlm.nih.gov/41118600Actively Recruiting
Phase 1
Age: 18Years - 75Years
All Genders
ID05759793
An Exploratory Study of Fully Human Anti-GPRC5D Chimeric Antigen Receptor T Cells (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
56 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
Researchers are evaluating the safety and effects of different doses of CAR-GPRC5D, a gene-modified T-cell therapy, in adults with relapsed or refractory multiple myeloma or plasma cell leukemia. This phase 1, single-center, open-label study focuses on patients who have undergone multiple previous treatments and have evidence of GPRC5D expression on their cancer cells. Participants will undergo apheresis to collect cells to manufacture the CAR-GPRC5D therapy. Before receiving the treatment, patients may have bridging therapy and will undergo lymphodepletion with fludarabine and cyclophosphamide for three days. Then, they will receive a single infusion of CAR-GPRC5D at one of three dose levels (1.0, 2.0, or 3.0 million CAR-T cells per kg). After infusion, patients will be monitored for at least two years, with long-term safety follow-up up to 15 years. Throughout the study, participants will have regular assessments including monitoring for side effects and adverse events, measuring disease response, and evaluating quality of life. Laboratory tests will track immune cell levels, drug presence, and related biomarkers. Researchers will observe outcomes such as dose-limiting toxicities, response rates, survival, and progression-free survival to understand the therapy's impact over time.
CONDITIONS
Brief Title
A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old, male or female
- Diagnosed with relapsed, progressive, or refractory multiple myeloma or plasma cell leukemia
- At least 3 prior lines of therapy including proteasome inhibitors and immunomodulatory agents
- Evidence of GPRC5D expression on tumor cells by immunohistochemistry or flow cytometry
- Measurable disease by specific laboratory or imaging criteria
- ECOG performance score of 0 to 2
- Estimated life expectancy of at least 12 weeks
- Adequate organ function including specific blood counts, liver, kidney, coagulation, oxygen saturation, and heart function
- Agreement to use effective contraception from consent until CAR T cell infusion
- Signed informed consent form prior to any study procedures
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
- Recent high-dose corticosteroid use (except certain forms)
- Uncontrolled hypertension
- Serious heart conditions including unstable angina, recent heart attack, severe heart failure, or serious arrhythmias
- Unstable systemic diseases such as severe liver, kidney, or metabolic disorders
- Second malignancies within past 5 years except certain treated cancers
- History of organ transplantation
- Major surgery within 2 weeks before leukapheresis or planned surgery during study
- Participation in another interventional clinical study within 1 month before consent
- Uncontrolled active infections requiring systemic treatment within 7 days before leukapheresis
- Positive tests for hepatitis B, hepatitis C, HIV, cytomegalovirus, or syphilis
- Pregnant or breastfeeding women
- Mental illness, consciousness disorders, or central nervous system diseases
- Other conditions deemed inappropriate by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - Variable time between apheresis and lymphodepletion
Participants undergo apheresis to collect cells for manufacturing CAR-GPRC5D CAR-T cells. Bridging therapy may be given between apheresis and lymphodepletion.
Visits as needed for apheresis and bridging therapy
Treatment
Duration - Approximately 1 week
Participants receive lymphodepletion chemotherapy for three consecutive days followed by a single infusion of CAR-GPRC5D CAR-T cells.
1 visit for lymphodepletion and 1 infusion visit
Follow-up
Duration - At least 2 years, up to 15 years
Participants are monitored for safety, response, and long-term outcomes for a minimum of 2 years after infusion. Lentiviral vector safety follow-up continues for up to 15 years.
Regular visits during the first 2 years and annual visits thereafter
Trial Site Locations
Total: 1 location
1
Ruijin Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
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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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