Safety and Efficacy of Autoimmune Cell Therapy for Patients With Hepatocellular Carcinoma
NCT ID: NCT05105815
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
23 participants
INTERVENTIONAL
2021-12-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IPM001
A neoantigen/tumor-specific antigen sensitized autoimmune cell injection
IPM001
IPM001 will be used against tumor cells
Interventions
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IPM001
IPM001 will be used against tumor cells
Eligibility Criteria
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Inclusion Criteria
* 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;
* 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;
Exclusion Criteria
* 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);
* Patients with a history of other malignant tumors in the past 5 years;
* Organ transplantation or Myelosuppression;
* History of drug abuse or alcohol abuse;
18 Years
75 Years
ALL
No
Sponsors
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Beijing Immupeutics Medicine Technology Limited
INDUSTRY
Peking University People's Hospital
OTHER
Huashan Hospital
OTHER
Responsible Party
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Hao Zhang
Professor
Locations
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Huashan hospital Fudan university
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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KY2021-567
Identifier Type: -
Identifier Source: org_study_id