Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Rimegepant
DrugRimegepant 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
DrugGlofitamab 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
DrugObinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.
CD19 CAR-T Cell Therapy
Biological/VaccineParticipants 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
DrugFludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
Cyclophosphamide
DrugCyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Rimegepant Plus Glofitamab and CD19 CAR-T Cell TherapyExperimental treatment 6 interventions
Group B: Glofitamab Plus CD19 CAR-T Cell TherapyActive comparator 5 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months after CAR-T cell infusionSecondary outcomes
1
Objective Response Rate
Objective response rate is defined as the proportion of participants who achieve complete response or partial response.
Time frame
Up to 24 months2
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.
Time frame
Day 28 after CAR-T cell infusion3
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.
Time frame
3 months after CAR-T cell infusion4
Progression-Free Survival
Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever occurs first.
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: