Phase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Myelofibrosis (CertainT-1)

CERo Therapeutics Holdings, Inc.5 个研究点分布在 1 个国家目标入组 18 人开始时间: 2025年4月7日最近更新: 2026年8月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: CERo Therapeutics Holdings, Inc.
入组人数: 18
试验地点: 5
主要终点: Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a ﬁrst in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efﬁcacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.

详细描述

CER-1236 is a first in class chimeric engulfment receptor T-cell therapy candidate that targets the Tim4 ligand.

The study is divided into Part 1 (escalation phase) and Part 2 (expansion phase).

Part 1 (Escalation Phase): The primary objectives of Part 1 are to deﬁne the safety of different doses of CER-1236 and to deﬁne the recommended dose for Part 2 (RP2D) of CER-1236.

Part 2 (Expansion Phase): The objective of the Part 2 expansion cohort is to evaluate the safety and efﬁcacy of CER-1236 in patients with acute myeloid leukemia.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients need to have a confirmed diagnosis of de novo or secondary AML, or myelodysplastic syndrome (MDS)/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.
•Absolute lymphocyte count >0.3 x 109/L prior to apheresis.
•Eastern cooperative oncology group (ECOG) performance status 0 to 1.

排除标准

•Prior therapy with a permanently integrated, genetically modified cell product.
•No measurable leukemia on the screening bone marrow evaluation prior to any bridging therapy.
•Active autoimmune disease or history of autoimmune disease requiring treatment within the prior 2 years. Patients with history of autoimmune thyroiditis or type 1 diabetes well controlled on replacement regimen are eligible.
•A known hypersensitivity or severe allergy to fludarabine, cyclophosphamide, or study drug components or diluents.
•Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the physician.
•Primary immunodeficiency disorder.