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

Fudan University

Status and phase: Enrolling; Phase 1

Conditions: HCC

Treatments: Biological: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :5.0×10^8（Third dose group）; Biological: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :2.5×10^8(Second dose group); Biological: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :1.0×10^8(First dose group)

Study type: Interventional

Funder types: Other

Identifiers

NCT06757881

B2024-272(2)

Details and patient eligibility

About

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

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-70 years old, male or female;
2. 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
3. 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);
4. Expected survival ≥3 months
5. 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;
6. Good compliance, willing and able to follow all research procedures, and cooperate with observation and follow-up.

Exclusion criteria

1. 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
2. Central nervous system metastases and clinically significant central nervous system diseases
3. Pregnant or lactating women;
4. The investigator believes that the subjects have any circumstances that make them unfit to participate in this clinical study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells

Experimental group

Treatment:

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

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

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