Rimegepant: Rimegepant will be administered orally at 75 mg every other day from the first day of lymphodepleting chemotherapy until Day 90 after CAR-T cell infusion.
Glofitamab: Glofitamab will be administered intravenously with step-up dosing. Participants will receive 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Cycle 2 Day 1. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation at 30 mg on Day 1 of each 21-day cycle for four cycles.
Obinutuzumab: Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.
CD19 CAR-T Cell Therapy: Participants will receive CD19-directed CAR-T cell therapy after lymphodepleting chemotherapy. The specific CAR-T product and dose will be determined according to the approved product label, institutional standard practice, and investigator discretion.
Fludarabine: Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
Cyclophosphamide: Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 2.
* 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.
Primary outcome measure(s)
Complete Response Rate at 6 Months — 6 months after CAR-T cell infusion Complete response rate at 6 months is defined as the proportion of participants who achieve complete response at 6 months after CAR-T cell infusion.
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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