RecruitingPhase 1NCT06757881

IL1RAP-targeting Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma

A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma

Sponsor

Shanghai Zhongshan Hospital

Enrollment

18 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma

Min Age: 18 YearsMax Age: 70 Years

Age 18-70 years old, male or female;
Patients with advanced hepatocellular carcinoma who are confirmed by histopathology and/or cytology to be ineligible for surgery and local radical therapy and who have developed tumor progression or toxicity intolerance following at least one standardized systemic therapy (including molecularly targeted agents and immune checkpoint inhibitors) or interventional therapy
Liver cancer subjects with stage II or III of China Liver Cancer Staging (CNLC) as defined by Barcelona Clinic Liver Cancer (BCLC) B/C level or the Code of Practice for Primary Liver Cancer Diagnosis and Treatment (2022 edition);
Expected survival ≥3 months
Before the start of the research related procedures, after explaining the research content, voluntarily participate and be able to sign the informed consent; Agree to and have the ability to follow study visits, imaging tests, laboratory tests, and other research procedures in the study plan;
Good compliance, willing and able to follow all research procedures, and cooperate with observation and follow-up.

Have had other uncured malignancies within the past 5 years or at the same time, except for in situ cancers considered clinically curable, such as cervical carcinoma in situ and basal cell carcinoma of the skin
Central nervous system metastases and clinically significant central nervous system diseases
Pregnant or lactating women;
The investigator believes that the subjects have any circumstances that make them unfit to participate in this clinical study.

BIOLOGICALGene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :1.0×10^8(First dose group)

Different dose groups

BIOLOGICALGene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :2.5×10^8(Second dose group)

Different dose groups

BIOLOGICALGene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :5.0×10^8（Third dose group）

Different dose groups

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06757881