Hepatocellular CarcinomaEarly Phase 1NCT05105815
Safety and Efficacy of Autoimmune Cell Therapy for Patients With Hepatocellular Carcinoma
A Early Phase 1 study testing IPM001 in people with Hepatocellular Carcinoma, run by Huashan Hospital at 1 site in China.
Trial summary
In this study, safety and effects of IPM001 vaccine on human hepatocellular carcinoma are going to be investigated, IPM001 is a neoantigen/tumor-specific antigen sensitized autoimmune cell injection Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- IPM001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 31 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- understand and voluntarily sign a written informed consent;
- Age: from 18 to 75 years, No restriction on gender;
- Patients must have primary hepatocellular carcinoma;
- Clinical stage: stage Ia~III a;
- Child-pugh score ≤7;
- HLA-A02 and consistent with ≥1 NeoAg or ≥2 aeTSA peptide bank;
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- ECOG PS score: 0~2;
- Laboratory values as follow:
- White blood cell count ≥ 3×109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 85g/L; Platelets: more than 5 × 1010/L; Total bilirubin:≤2 × ULN; Serum AST(GOT) and ALT(GPT)≤2.5 × ULN; Albumin ≥3.0 g/dL (30 g/L); Serum creatinine: less than 1.5 × ULN; Coagulation time was basically normal, PT extension ≤4s; No serious cardiopulmonary disease;
- Blood collection body weight: male > 50 kg, female > 45 kg;
- No obvious hereditary diseases;
- Expected survival: more than 6 months;
Who cannot join
- Patient has known distant organ metastasis;
- Suffer from lymphoma or leukemia or MDS (myelodysplastic syndrome), etc.;
- Woman be pregnant or lactating;
- Suffer from mental or neurological diseases that are resistant to control;
- The investigator judges that it is not suitable to participate in this clinical research (such as poor compliance, etc.);
- Patients infected with human immunodeficiency virus (commonly known as AIDS) or Treponema pallidum (commonly known as syphilis);
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- Patients with a history of other malignant tumors in the past 5 years;
- Organ transplantation or Myelosuppression;
- History of drug abuse or alcohol abuse;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study on the Safety and Effectiveness of Autoimmune Cell Therapy Sensitized With Liver Cancer Neoantigen in Patients With High Risk of Recurrence After Surgical Resection of Primary Hepatocellular Carcinoma
In this study, safety and effects of IPM001 vaccine on human hepatocellular carcinoma are going to be investigated, IPM001 is a neoantigen/tumor-specific antigen sensitized autoimmune cell injection
- Conditions
- Hepatocellular Carcinoma
- Being tested
- IPM001
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPM001Biological
IPM001 will be used against tumor cells
| Study group | Role | What they receive |
|---|---|---|
| IPM001 | Experimental | A neoantigen/tumor-specific antigen sensitized autoimmune cell injection Receives: Biological: IPM001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
The time between the NeoAg/aeTSA CTL initiation and the onset of tumor recurrence or death from any cause
Measured: 18 months
Secondary outcomes (2)
OS
From the beginning of NeoAg/aeTSA CTL initiation to the time of death from any cause
Measured: 24 months
EORTC-QLQ30
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start31 Dec 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Immupeutics Medicine Technology Limited, Peking University People's Hospital
- Responsible party
- Principal investigator, Hao Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105815
- Sponsor's protocol ID
- KY2021-567
- Status last verified
- Oct 2021
- First submitted
- 23 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Safety and Effectiveness of Autoimmune Cell Therapy Sensitized With Liver Cancer Neoantigen in Patients With High Risk of Recurrence After Surgical Resection of Primary Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05105815
- Acronym / sponsor ID
- KY2021-567
- Conditions
- Hepatocellular Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Beijing Immupeutics Medicine Technology Limited, Peking University People's Hospital
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Nov 2021 (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.
In this study, safety and effects of IPM001 vaccine on human hepatocellular carcinoma are going to be investigated, IPM001 is a neoantigen/tumor-specific antigen sensitized autoimmune cell injection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPM001 | Experimental | Biological: IPM001A neoantigen/tumor-specific antigen sensitized autoimmune cell injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- understand and voluntarily sign a written informed consent;
- Age: from 18 to 75 years, No restriction on gender;
- Patients must have primary hepatocellular carcinoma;
- Clinical stage: stage Ia~III a;
- Child-pugh score ≤7;
Key exclusion criteria (9 listed)
- Patient has known distant organ metastasis;
- Suffer from lymphoma or leukemia or MDS (myelodysplastic syndrome), etc.;
- Woman be pregnant or lactating;
- Suffer from mental or neurological diseases that are resistant to control;
- The investigator judges that it is not suitable to participate in this clinical research (such as poor compliance, etc.);
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 |
|---|---|---|
| IPM001IPM001 will be used against tumor cells | Biological | IPM001 |
Primary outcome
DFS
Time frame: 18 months
The time between the NeoAg/aeTSA CTL initiation and the onset of tumor recurrence or death from any cause
2 secondary outcomes
OS
Time frame: 24 months
EORTC-QLQ30
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IPM001 in people with Hepatocellular Carcinoma, run by Huashan Hospital at 1 site in China.
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 12 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Nov 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Zhang, PhD (8613917775888, drhao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2021.