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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат Obinutuzumab
  Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.
• Биопрепарат 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.
• Препарат Fludarabine
  Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
• Препарат Cyclophosphamide
  Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.

Первичные конечные точки

• Complete Response Rate at 6 Months [Срок оценки: 6 months after CAR-T cell infusion]

Вторичные конечные точки (7)

• Objective Response Rate [Срок оценки: Up to 24 months]
• Complete Response Rate at Day 28 [Срок оценки: Day 28 after CAR-T cell infusion]
• Complete Response Rate at 3 Months [Срок оценки: 3 months after CAR-T cell infusion]
• Progression-Free Survival [Срок оценки: Up to 24 months]
• Duration of Response [Срок оценки: Up to 24 months]
• Overall Survival [Срок оценки: Up to 24 months]
• Adverse Events [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07613788 · RIME-CART

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗