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

April 27, 2026 updated by: Shanghai Zhongshan Hospital

A Phase 1 Study of 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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Zhongshan Hospital Affiliated to Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells
Biological: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :1.0×10^8(First dose group)
Different dose groups
Biological: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :2.5×10^8(Second dose group)
Different dose groups
Biological: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :5.0×10^8（Third dose group）
Different dose groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Dose Limited Toxicity
Time Frame: Within 28 days after the cell infusion
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
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
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)
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
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Curative effect evaluation
Time Frame: 3 months after cell infusion
3-month objective response rate (ORR); 、
3 months after cell infusion
Disease control rate (DCR)
Time Frame: 3 months, 6 months, 1 year, 2years after cell infusion
3 months, 6 months, 1 year, 2years after cell infusion
Changes of serum IL1RAP level
Time Frame: 3 months, 6 months, 1 year, 2years after cell infusion
3 months, 6 months, 1 year, 2years after cell infusion
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
3 months, 6 months, 1 year, 2years after cell infusion
Progression-free survival (PFS)
Time Frame: 3 months, 6 months, 1 year, 2years after cell infusion
3 months, 6 months, 1 year, 2years after cell infusion
Median PFS
Time Frame: 3 months, 6 months, 1 year, 2years after cell infusion
3 months, 6 months, 1 year, 2years after cell infusion
Time to remission (TTR)
Time Frame: 3 months, 6 months, 1 year, 2years after cell infusion
3 months, 6 months, 1 year, 2years after cell infusion
Duration of response after administration (DOR)
Time Frame: 3 months, 6 months, 1 year, 2years after cell infusion
3 months, 6 months, 1 year, 2years after cell infusion
Survival time: Median overall survival (mOS)
Time Frame: 6 months, 1 year, 2years after cell infusion
6 months, 1 year, 2years after cell infusion
OS rate
Time Frame: 6 months, 1 year, 2years after cell infusion
6 months, 1 year, 2years after cell infusion
PFS rate
Time Frame: 3 months, 6 months, 1 year, 2years after cell infusion
3 months, 6 months, 1 year, 2years after cell infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

August 27, 2025

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 28, 2024

First Posted (Actual)

January 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2024-272(2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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