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

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 Overview

• Status: Not yet recruiting
• Conditions: Relapsed/Refractory Large B-cell Lymphoma (LBCL)
• Intervention / Treatment: Drug: Rimegepant; Drug: Glofitamab; Drug: Obinutuzumab; Biological: CD19 CAR-T Cell Therapy; Drug: Fludarabine; Drug: Cyclophosphamide

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Weili Zhao; Phone Number: +862164370045 Ext. 610707; Email: zwl_trial@163.com
• Study Contact Backup: Name: Rong Shen; Phone Number: +862164370045 Ext. 610707; Email: rongshen510@yeah.net

Study Locations

• China
  • China
    • Shanghai, China, China, 200020
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Weili Zhao; Phone Number: 64370045; Email: zwl_trial@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy; 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.	Drug: 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.; Drug: 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.; Drug: Obinutuzumab; Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.; Biological: 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.; Drug: Fludarabine; Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.; Drug: Cyclophosphamide; Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
Active Comparator: Glofitamab Plus CD19 CAR-T Cell Therapy; 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.	Drug: 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.; Drug: Obinutuzumab; Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.; Biological: 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.; Drug: Fludarabine; Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.; Drug: Cyclophosphamide; Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate at 6 Months	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.	6 months after CAR-T cell infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Objective response rate is defined as the proportion of participants who achieve complete response or partial response.	Up to 24 months
Complete Response Rate at Day 28	Complete response rate at Day 28 is defined as the proportion of participants who achieve complete response at Day 28 after CAR-T cell infusion.	Day 28 after CAR-T cell infusion
Complete Response Rate at 3 Months	Complete response rate at 3 months is defined as the proportion of participants who achieve complete response at 3 months after CAR-T cell infusion.	3 months after CAR-T cell infusion
Progression-Free Survival	Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever occurs first.	Up to 24 months
Duration of Response	Duration of response is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first.	Up to 24 months
Overall Survival	Overall survival is defined as the time from randomization to death from any cause.	Up to 24 months
Adverse Events	Incidence and severity of adverse events will be assessed throughout the study.	Up to 24 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: May 23, 2026
• First Submitted That Met QC Criteria: May 23, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence; Organic Chemicals; Hydrocarbons; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclophosphamide; fludarabine; obinutuzumab; glofitamab; rimegepant sulfate
• Other Study ID Numbers: RIME-CART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No