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
ID05219721
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 Chunrui Li · Updated on 2025-06-11
18
Participants Needed
1
Research Sites
4 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
Researchers are evaluating the safety and effectiveness 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, open-label study focuses on patients who have already received multiple prior treatments. The trial aims to understand how well these modified T cells work and how safe they are for this patient group. Participants will undergo apheresis to collect their cells, which are then modified to create CAR-GPRC5D T cells. Before receiving the therapy, patients undergo lymphodepletion with fludarabine and cyclophosphamide for three days. They will then get a single infusion of CAR-GPRC5D at one of three dose levels. Bridging therapy is allowed between cell collection and lymphodepletion. After treatment, participants will be followed for at least two years, with long-term safety monitoring up to 15 years. During the study, patients will be closely monitored for side effects and treatment responses. Researchers will assess adverse events, response rates, survival, and quality of life. They will also track the therapy's presence and activity in the body and evaluate immune system markers. The study involves regular visits, lab tests, and assessments over the follow-up period to gather comprehensive safety and effectiveness data.
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 between 18 and 75 years, male or female
- Diagnosis of relapsed or refractory multiple myeloma or plasma cell leukemia with disease recurrence, progression, or refractory status
- At least three prior lines of therapy including chemotherapy with proteasome inhibitors and immunomodulatory agents
- Evidence of GPRC5D expression on tumor cells confirmed by immunohistochemistry or flow cytometry
- Measurable disease based on bone marrow plasma cells, serum or urine M-protein, serum free light chain levels, or extramedullary lesion size
- ECOG performance status between 0 and 2
- Estimated life expectancy of at least 12 weeks
- Adequate organ function including specific blood counts, liver and kidney function, coagulation status, oxygen saturation above 91%, and left ventricular ejection fraction of 50% or higher
- Agreement to use effective contraception for one year from informed consent to CAR T cell infusion
- Signed informed consent form approved by ethics board
You will not qualify if you...
- Presence of graft-versus-host disease or need for long-term immunosuppressive therapy
- Recent anti-cancer treatments including certain monoclonal antibodies, cytotoxic therapy, proteasome inhibitors, immunomodulatory agents, or other anti-tumor treatments within specified days before leukapheresis
- Use of high-dose corticosteroids within 7 days prior to screening except for specific exceptions
- Uncontrolled hypertension
- Serious heart diseases such as unstable angina, recent myocardial infarction, severe heart failure, or serious arrhythmias
- Unstable systemic diseases requiring medical treatment including severe liver, kidney, or metabolic diseases
- Second malignancies in the past 5 years except specific successfully treated cancers
- History of organ transplantation
- Major surgery within 2 weeks prior to leukapheresis or planned surgery during the study period
- Participation in another interventional clinical study within 1 month before informed consent
- Uncontrolled active infections 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 disorders, or central nervous system diseases
- Other conditions deemed inappropriate by researchers for study inclusion
AI-Screening
AI-Powered Screening
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1
2
3
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 duration between apheresis and lymphodepletion
Participants undergo apheresis to collect cells for manufacturing CAR-GPRC5D T cells. Bridging therapy may be given between apheresis and lymphodepletion.
1 visit for apheresis and additional visits depending on bridging therapy
Treatment
Duration - Approximately 1 week including lymphodepletion and CAR-GPRC5D infusion
Participants receive lymphodepletion with fludarabine and cyclophosphamide for three consecutive days, followed by a single infusion of CAR-GPRC5D cells.
4 visits (3 days for lymphodepletion and 1 infusion visit)
Follow-up
Duration - At least 2 years, with extended safety monitoring up to 15 years
Participants are followed for a minimum of 2 years after infusion to monitor safety, treatment response, and long-term effects, including lentiviral vector safety for up to 15 years.
Regular visits over 2 years for assessments; extended monitoring visits as scheduled
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
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Research Team
C
Chunrui Li
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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