A Multicenter, Open-label, Non-randomized, Single-arm Phase 1/2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma

Официальное название

A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase 1/2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma

Обзор

This is a clinical research study for people with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoma. The study will test a new treatment called "autologous nano CD5-CAR T cells". These are your own immune cells that have been changed in a lab to recognize and kill cancer cells. This study has two parts: Phase 1 to test the safety and best dose of the treatment, and Phase 2 to see how well it works. You may receive the study treatment if you meet all the eligibility criteria. The main things the study will look at are: how safe the treatment is, how many people's cancer goes away or gets better, and how long the effect lasts. Possible risks include fever, low blood pressure, and infection, which the study team will monitor closely.

Подробное описание

This is a multicenter, open-label, non-randomized, single-arm Phase 1/2 study evaluating the safety and efficacy of autologous nano CD5-CAR T cells in adult and adolescent patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) who have failed prior standard therapies.

The Phase 1 portion uses a dose-escalation design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The Phase 2 portion will enroll patients at the RP2D to evaluate the overall response rate (ORR) per independent review committee (IRC) assessment.

Secondary objectives include assessment of duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety profile including adverse events (AEs) of special interest such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

Key inclusion criteria include confirmed diagnosis of r/r T-ALL/T-LBL, adequate organ function, and measurable disease. Key exclusion criteria include active severe infection, prior allogeneic stem cell transplantation within 100 days, and known central nervous system involvement that is not controlled.

The study will enroll approximately \[X\] patients at multiple investigational sites in China. All patients will receive lymphodepleting chemotherapy followed by infusion of autologous nano CD5-CAR T cells. Safety assessments will be performed throughout the study period, including regular laboratory tests and clinical evaluations.

Вмешательства

• Биопрепарат Autologous nano CD5-CAR T Cells
  Autologous CD5-targeted CAR-T cells engineered with a novel nano antibody-based chimeric antigen receptor. Patients receive lymphodepleting chemotherapy (fludarabine 30 mg/m²/day + cyclophosphamide 250 mg/m²/day for 3 days) followed by a single intravenous infusion of CAR-T cells. The study uses a dose-escalation design with two main dose levels: 1.0×10\^6 cells/kg and 2.0×10\^6 cells/kg, with a backup low dose of 0.5×10\^6 cells/kg for use in case of insufficient cell yield.

Первичные конечные точки

• Incidence of Dose-Limiting Toxicities (DLT) [Срок оценки: 28 days after CAR-T cell infusion]

Критерии участия

Критерии включения

• Age 3 to 70 years old
• Diagnosed with CD5-positive relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)
• ECOG performance status 0-2
• Adequate organ function (renal, hepatic, cardiac, pulmonary)
• Able to understand and sign informed consent

Критерии исключения

• Active severe infection or uncontrolled sepsis
• History of allogeneic stem cell transplantation within 3 months
• Severe autoimmune disease or immunodeficiency
• Prior CD5-targeted therapy
• Pregnant or breastfeeding women
• Any condition that, in the investigator's opinion, would compromise safety or compliance with the protocol

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07678307 · IIT2026011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗