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
Qualifiers
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
Treatments tested in this trial
- Rimegepant
- Glofitamab
- Obinutuzumab
- CD19 CAR-T Cell Therapy
- Fludarabine
- Cyclophosphamide
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov