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NCT Number: NCT05779917

Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers

The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location status: Recruiting

Location contact

Zhenfeng Zhang, MD, PHD

CONTACT

[email protected]

+862039195966

About this study

  • Choose appropriate patients with advanced pancreatic cancer or other cancers, with written consent for this study;
  • Perform biopsy to determine the expression of Mesothelin of the tumors by western blotting or IHC;
  • Collect blood from the patients and isolate mononuclear cells, activate the T cells and transfect the T cells with Mesothelin targeting CAR, amplify the transfected T cells as needed, test the quality and killing activity of the CAR-T cells and then transfer them back the patients via systemic or 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 that expresses Mesothelin protein; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay; 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

CAR-T cells

Biological

Transfer CAR-T cells 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 Mesothelin-CAR T cells, 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.

  2. Median CAR-T cell persistence

    Time frame: Six years

    Median CAR-T cell persistence will be measured by quantitative rt-PCR.

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

Collaborators

  • Fapon Biotherapy Inc.

Registry information

Official study title

Mesothelin/GPC3/GUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial

Important dates

Study start
2023
Primary completion
2029
Study completion
2036
First posted
Mar 22, 2023
Registry last updated
Jun 25, 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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