NCT07613788Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy in Patients With High-Risk Relapsed/Refractory Large B-Cell Lymphoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 100
- Locations
- 1
Study Overview
Brief Summary
This study is designed to evaluate the efficacy and safety of rimegepant in combination with glofitamab and CD19 CAR-T cell therapy in patients with high-risk relapsed/refractory large B-cell lymphoma. Eligible patients will be randomized to receive glofitamab plus CD19 CAR-T cell therapy with or without rimegepant. The primary endpoint is complete response rate at 6 months after CAR-T cell infusion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able to understand and voluntarily sign the written informed consent form.
- •Age 18 years or older.
- •Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression.
- •Relapsed or refractory disease after at least one prior line of systemic therapy.
- •Prior treatment must have included an anthracycline-containing chemotherapy regimen and an anti-CD20 monoclonal antibody.
- •Considered suitable by the investigator to receive glofitamab and CD19 CAR-T cell therapy.
- •Presence of at least one high-risk feature, including extranodal involvement, bulky disease, or TP53 abnormality.
- •ECOG performance status of 0 to
- •Life expectancy of at least 12 weeks.
- •Adequate bone marrow, hepatic, renal, pulmonary, and cardiac function as determined by the investigator.
- •Participants of reproductive potential must agree to use effective contraception during the study period.
- •Able and willing to comply with the study protocol, in the investigator's judgment.
Exclusion Criteria
- •History of hypersensitivity to any study treatment or related compounds.
- •Active or uncontrolled infection requiring systemic treatment.
- •History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- •Uncontrolled or clinically significant viral infection as defined by the protocol.
- •Known central nervous system involvement by lymphoma or clinically significant central nervous system disease that may interfere with study treatment or safety assessment.
- •Severe or uncontrolled cardiovascular disease.
- •Severe autoimmune disease or immune-mediated disease that may interfere with study treatment or safety assessment.
- •Known or suspected history of hemophagocytic lymphohistiocytosis.
- •Recent thromboembolic event before screening.
- •History of another malignancy within 5 years before screening, except adequately treated carcinoma in situ or non-melanoma skin cancer.
- •Receipt of prohibited anticancer therapy, immunosuppressive therapy, live attenuated vaccine, or other prohibited treatment within the protocol-specified period before enrollment.
- •Pregnant or breastfeeding women, or participants planning pregnancy during the study period.
- •Concurrent participation in another interventional clinical trial.
- •Need for prohibited concomitant medications that cannot be discontinued or substituted.
- •Any condition that, in the investigator's judgment, makes the participant unsuitable for study treatment or study participation.
Investigators
Zhao Weili
Professor and Director, Shanghai Institute of Hematology
Ruijin Hospital
Study Sites (1)
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