Autologous Neoantigen-Specific T-Cell Therapy for Advanced Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University
About this trial
The goal of this open-label, single-arm phase I/II clinical trial is to evaluate the feasibility, safety, and anti-tumor efficacy of the autologous neoantigen-specific T-cell therapy (iNeo-Vac-T01) in patients with advanced hepatocellular carcinoma who have failed second-line or later systemic therapies.
Eligibility criteria
Qualifiers
Aged 18 to 75 years (inclusive)
Radiologically measurable disease per RECIST v1.1
White blood cell count (WBC) ≥3.0 × 10⁹/L
Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
Disqualifiers
Adequately treated basal cell or squamous cell skin cancer
Carcinoma in situ of the cervix
Detectable HBV DNA (if HBsAg positive or HBcAb positive)
Detectable HCV RNA
Trial design
Treatments tested in this trial
- iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine
- iNeo-Vac-T01 Personalized T Cell Injection
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Zhejiang University
Lead sponsor
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborator
Source ClinicalTrials.gov