CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma

Официальное название

An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed or Refractory (R/R) LBCL

Обзор

This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.

Подробное описание

This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate efficacy，safety and pharmacokinetics(PK) of relma-cel.

Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10\^8 CAR+T cells.The indication for this application is R/R LBCL and the recommended dose is 1×10\^8 CAR+T cells.

Вмешательства

• Биопрепарат Relma-cel
  Relma-cel will be administered at one dose level:1×10\^8 CAR+T cells

Первичные конечные точки

• Objective response rate (ORR) in LBCL subjects [Срок оценки: 3 months]

Вторичные конечные точки (10)

• Objective response rate (ORR) [Срок оценки: 3 months]
• Best objective response rate ( Best ORR) in LBCL subjects [Срок оценки: up to 1 year after Relma-cel infusion]
• Complete response rate (CRR) in LBCL subjects [Срок оценки: up to 1 year after Relma-cel infusion]
• Progression-free survival (PFS) [Срок оценки: up to 1 year after Relma-cel infusion]
• Overall survival (OS) [Срок оценки: up to 1 year after Relma-cel infusion]
• Duration of response (DOR) [Срок оценки: up to 1 year after Relma-cel infusion]
• Pharmacokinetic(PK)-Cmax of Relma-cel [Срок оценки: up to 1 year after Relma-cel infusion]
• Pharmacokinetic(PK)-Tmax of Relma-cel [Срок оценки: up to 1 year after Relma-cel infusion]
• Pharmacokinetic(PK)-AUC of Relma-cel [Срок оценки: up to 1 year after Relma-cel infusion]
• Adverse events (AEs) [Срок оценки: up to 1 year after Relma-cel infusion]

Критерии участия

Критерии включения

• ≥18 years old;
• Sign on the informed consent;
• Subjects must have histologically confirmed Large B-cell Lymphoma;
• Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT);
• Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
• Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
• Adequate organ function;
• Adequate vascular access for leukapheresis procedure;
• Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
• Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
• Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.

Критерии исключения

• Primary CNS lymphoma;
• History of another primary malignancy that has not been in remission for at least 2 years;
• Subjects has HBV,HCV,HIV or syphilis infection at the time of screening;
• Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
• Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
• Presence of acute or chronic graft-versus-host disease(GVHD);
• History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
• Pregnant or nursing woman;
• Subjects using of any chemotherapy,corticosteroid,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
• Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
• Received CAR T-cell or other genetically-modified T-cell therapy previously.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Cancer Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06479356 · JWCAR029-117

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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