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Recruiting

NCT Number: NCT06195293

Anti-cancer Neoantigen Polypeptide Vaccine to Treat Solid Tumors

The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.

Recruiting

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

  • Choose appropriate patients with advanced solid cancers, with written consent for this study;
  • Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;
  • Produce appropriate polypeptide vaccine for human use and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;
  • To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
  • Evaluate the clinical results as needed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with advanced cancer; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

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Exclusion criteria

  • Had accepted gene therapy before;
  • Severe virus infection such as HBV, HCV, HIV, et al;
  • Known HIV positivity;
  • Active infectious disease related to bacteria, virus,fungi,et al;
  • Other severe diseases that the investigators consider not appropriate;
  • Pregnant or lactating women;
  • Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
  • Other conditions that the investigators consider not appropriate.

Treatment and study plan

Neoantigen polypeptide vaccine

Biological

Deliver neoantigen polypeptide vaccine into patients for anti-ancer therapy.

Primary outcomes

  1. Number of Patients with Dose Limiting Toxicity

    Time frame: Six months

    A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.

Secondary outcomes

  1. Percent of Patients with best response as either complete remission or partial remission.

    Time frame: Six months

    Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.

Study contacts

Contact information is provided by the study sponsor or research team.

Bingjia He, MD

CONTACT

[email protected]

+862039195965

Zhenfeng Zhang, MD, PhD

CONTACT

[email protected]

0086-020-39195965

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

Anti-cancer Neoantigen Polypeptide Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial

Important dates

Study start
2024
Primary completion
2029
Study completion
2037
First posted
Jan 8, 2024
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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