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NCT Number: NCT06757881

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HCC

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Biological

Different dose groups

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

Biological

Different dose groups

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

Biological

Different dose groups

Primary outcomes

  1. Number of participants with Dose Limited Toxicity

    Time frame: Within 28 days after the cell infusion

  2. Number of participants with treatment associated adverse events (AE) and serious adverse events (SAE) according to CTCAE v5.0

    Time frame: 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

  3. Number of participants with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)

    Time frame: 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

  4. Number of participants with treatment associated changes in clinically significant laboratory safety test values

    Time frame: 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

Secondary outcomes

  1. Curative effect evaluation

    Time frame: 3 months after cell infusion

    3-month objective response rate (ORR); 、

  2. Disease control rate (DCR)

    Time frame: 3 months, 6 months, 1 year, 2years after cell infusion

  3. Changes of serum IL1RAP level

    Time frame: 3 months, 6 months, 1 year, 2years after cell infusion

  4. Changes of copy number and absolute value of CAR-T cells targeting IL1RAP in peripheral blood

    Time frame: 3 months, 6 months, 1 year, 2years after cell infusion

  5. Progression-free survival (PFS)

    Time frame: 3 months, 6 months, 1 year, 2years after cell infusion

  6. Median PFS

    Time frame: 3 months, 6 months, 1 year, 2years after cell infusion

  7. Time to remission (TTR)

    Time frame: 3 months, 6 months, 1 year, 2years after cell infusion

  8. Duration of response after administration (DOR)

    Time frame: 3 months, 6 months, 1 year, 2years after cell infusion

  9. Survival time: Median overall survival (mOS)

    Time frame: 6 months, 1 year, 2years after cell infusion

  10. OS rate

    Time frame: 6 months, 1 year, 2years after cell infusion

  11. PFS rate

    Time frame: 3 months, 6 months, 1 year, 2years after cell infusion

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jan 3, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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