HCCPhase 1NCT06757881

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

A Phase 1 study testing Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :1.0×10^8(First dose group), Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :2.5×10^8(Second dose group) and Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :5.0×10^8（Third dose group） in people with HCC, run by Shanghai Zhongshan Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: HCC
What is being tested?: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :1.0×10^8(First dose group), Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :2.5×10^8(Second dose group) and Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :5.0×10^8（Third dose group）
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteChina
Study dates: 1 Jan 2025to 1 Dec 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: 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

Conditions: HCC
Being tested: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :1.0×10^8(First dose group), Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :2.5×10^8(Second dose group), Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :5.0×10^8（Third dose group）

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06757881
Study group	Role	What they receive
Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells	Experimental	Not described Receives: 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）

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with Dose Limited Toxicity
Measured: 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
Measured: 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)
Measured: 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
Measured: 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 (11)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20251 Dec 2027

First posted3 Jan 2025
Study start1 Jan 2025
Primary completion27 Aug 2025
Study completion1 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HCCStudies of the same condition, open and under way.
More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT06757881
Sponsor's protocol ID: B2024-272(2)
Status last verified: Dec 2025
First submitted: 20 Dec 2024
Last updated: 1 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HCC trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06757881
Acronym / sponsor ID: B2024-272(2)
Conditions: HCC
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 3 participants (actual)
Lead sponsor: Shanghai Zhongshan HospitalUniversity, hospital or other
Study start: 1 Jan 2025 (actual)
Primary completion: 27 Aug 2025 (actual)
Study completion: 1 Dec 2027 (estimated)
First posted: 3 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells	Experimental	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）

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

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

11 secondary outcomes

Curative effect evaluation
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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Individual participant dataSharing planned: No

Related trials for HCC

RecruitingPhase 2
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RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
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RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Dose Limited Toxicity (time frame: Within 28 days after the cell infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06757881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.