Clinical trial · Interventional
Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Large B-cell Lymphoma (LBCL) | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CAR-T Cell Therapy | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Glofitamab | Drug | Glofitamab | ALIAS |
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
| Rimegepant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy
- description
- Participants will receive rimegepant in combination with glofitamab and CD19 CAR-T cell therapy. 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 will be given with obinutuzumab pretreatment and step-up dosing, followed by CD19 CAR-T cell therapy after lymphodepleting chemotherapy. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation according to the study protocol.
- interventionNames
- Drug: Rimegepant
- Drug: Glofitamab
- Drug: Obinutuzumab
- Biological: CD19 CAR-T Cell Therapy
- Drug: Fludarabine
- Drug: Cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- Glofitamab Plus CD19 CAR-T Cell Therapy
- description
- Participants will receive glofitamab in combination with CD19 CAR-T cell therapy. Glofitamab will be given with obinutuzumab pretreatment and step-up dosing, followed by CD19 CAR-T cell therapy after lymphodepleting chemotherapy. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation according to the study protocol.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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