Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL

Sponsor
Ruijin Hospital
Study ID
NCT07613788
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Relapsed/Refractory Large B-cell Lymphoma (LBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    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 — DRUG
    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 — DRUG
    Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.
  • CD19 CAR-T Cell Therapy — BIOLOGICAL
    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 — DRUG
    Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Nov 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Complete Response Rate at 6 Months [ Time Frame: 6 months after CAR-T cell infusion ]

Central Contacts