Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :1.0×10^8(First dose group): Different dose groups
Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :2.5×10^8(Second dose group): Different dose groups
Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :5.0×10^8（Third dose group）: Different dose groups
Study summary
A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with Dose Limited Toxicity — Within 28 days after the cell infusion
Number of participants with treatment associated adverse events (AE) and serious adverse events (SAE) according to CTCAE v5.0 — From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins
Number of participants with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) — From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins
Number of participants with treatment associated changes in clinically significant laboratory safety test values — From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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