Active, not recruitingNCT06757881Updated May 1, 2026

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

A Phase 1 interventional study of Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :1.0×10^8(First dose group) and Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :2.5×10^8(Second dose group) in HCC, sponsored by Shanghai Zhongshan Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Shanghai Zhongshan Hospital · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 3
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: All

Study summary

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

Conditions studied

In context

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 3 participants (actual)

Study arms

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) · 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 :5.0×10^8（Third dose group）

Interventions

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

What researchers measure

Primary outcomes

Number of participants with Dose Limited Toxicity
Time frame: 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
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
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

Curative effect evaluation
3-month objective response rate (ORR); 、
Time frame: 3 months after cell infusion
Disease control rate (DCR)
Time frame: 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
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
Progression-free survival (PFS)
Time frame: 3 months, 6 months, 1 year, 2years after cell infusion
Median PFS
Time frame: 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
Duration of response after administration (DOR)
Time frame: 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
OS rate
Time frame: 6 months, 1 year, 2years after cell infusion
PFS rate
Time frame: 3 months, 6 months, 1 year, 2years after cell infusion

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06757881
Lead sponsor: Shanghai Zhongshan Hospital
Responsible party: Sponsor
First posted: Jan 3, 2025
Start date: Jan 1, 2025
Primary completion: Aug 27, 2025
Completion: Dec 1, 2027 (estimated)
Last update: May 1, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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