GPRC5D-Targeted CAR T Cells for Myeloma.
Sham Mailankody, Sean M Devlin, Jonathan Landa...
https://pubmed.ncbi.nlm.nih.gov/36170501Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID05998928
A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Received Three or More Lines of Therapy
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2023-11-13
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
G
Guangzhou Bio-gene Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment using bispecific BCMA-GPRC5D Chimeric Antigen Receptor (CAR) T-cells in adults with relapsed or refractory multiple myeloma who have already received three or more lines of therapy. This phase 2 study focuses on patients whose disease has progressed despite prior treatments, aiming to assess the safety and effectiveness of this investigational therapy, especially for those with limited options due to low or negative BCMA expression on tumor cells. Participants receive lymphodepletion chemotherapy with fludarabine and cyclophosphamide for three consecutive days before a single infusion of BCMA-GPRC5D CAR-T cells at a dose based on body weight. The study is open-label and single-arm, meaning all patients receive this investigational treatment without a comparison group. The treatment strategy is designed to target two antigens on myeloma cells to improve response rates and reduce the chance of the cancer escaping treatment. During the study, patients are closely monitored for treatment-related side effects and the therapy's behavior in the body over up to two years. Assessments include measuring the presence and amount of cancer markers, overall response, duration of response, survival rates, and immune cell activity. Regular evaluations of liver, kidney, heart function, and oxygen levels help ensure participant safety. The study lasts long enough to capture meaningful data about both benefits and risks of this CAR-T cell therapy in this patient population.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Received Three or More Lines of Therapy
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patient or legal guardian voluntarily signs informed consent
- Age between 18 and 75 years
- Diagnosis of multiple myeloma according to international standards
- Presence of measurable disease with specified protein or light chain levels
- Relapsed or refractory after at least three prior therapies including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody
- Relapsed, refractory, or primary refractory disease
- Last treatment ineffective or disease progression within 60 days after last therapy
- Recovery from toxicity of last therapy (less than grade 2)
- ECOG performance status of 1-2 and expected survival of at least 3 months
- Adequate liver, kidney, and cardiopulmonary function as defined by lab values and tests
- Able to establish venous access and no contraindications for apheresis
You will not qualify if you...
- Other malignancies diagnosed or treated within past 3 years
- Prior anti-tumor therapies before apheresis including various drugs and treatments
- Central nervous system involvement
- Presence of specific syndromes like Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL amyloidosis
- Positive tests for hepatitis B, hepatitis C, HIV, CMV, or EBV with levels above detection limits
- Severe allergy history
- Severe systemic diseases or poor organ function
- Graft versus host disease within 6 months or requiring immunosuppressive treatment
- Active autoimmune or inflammatory diseases of the nervous system
- Oncology emergencies needing treatment prior to screening or infusion
- Uncontrolled infections requiring antibiotics
- Recent exposure to hematopoietic growth factors or corticosteroids before apheresis
- Major surgery within 4 weeks before lymphodepletion or planned during study
- Live attenuated vaccine within 4 weeks before screening
- Severe mental illness
- Addiction to alcohol or drugs
- Pregnancy, lactation, or planned fertility within two years after CAR-T infusion
- Other conditions deemed inappropriate by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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)
Treatment
Duration - Approximately 2 weeks
Participants receive lymphodepletion chemotherapy with fludarabine and cyclophosphamide for 3 consecutive days, followed by a single infusion of BCMA-GPRC5D CAR-T cells.
1 baseline visit and 1 treatment visit
Follow-up
Duration - Up to 2 years after infusion
Participants are monitored for safety and efficacy outcomes after CAR-T cell infusion.
Regular visits during 2-year follow-up period
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
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Research Team
H
Heng Mei
C
Chenggong 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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Published Research Related To This Trial
Defining an Optimal Dual-Targeted CAR T-cell Therapy Approach Simultaneously Targeting BCMA and GPRC5D to Prevent BCMA Escape-Driven Relapse in Multiple Myeloma.
Carlos Fernández de Larrea, Mette Staehr, Andrea V Lopez...
https://pubmed.ncbi.nlm.nih.gov/33089218