Menu
Recruiting NCT05779917

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

Phase I Interventional Pancreas Cancer CAR-T Cell Therapy Mesothelin Solid Tumor, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CAR-T cells.
Who it may be relevant to
Registry conditions: Pancreas Cancer, CAR-T Cell Therapy, Mesothelin, Solid Tumor, Adult. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

1. Choose appropriate patients with advanced pancreatic cancer or other cancers, with written consent for this study; 2. Perform biopsy to determine the expression of Mesothelin of the tumors by western blotting or IHC; 3. 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; 4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied; 5. Evaluate the clinical results as needed.

Interventions

  • Biological CAR-T cells
    Transfer CAR-T cells into patients for anti-ancer therapy.

Primary outcome measures

  • Number of Patients with Dose Limiting Toxicity [Time frame: six months]
Secondary outcome measures (2)
  • Percent of Patients with best response as either complete remission or partial remission. [Time frame: six months]
  • Median CAR-T cell persistence [Time frame: Six years]

Eligibility criteria

Inclusion criteria

1\. 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.

\-

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. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT05779917 · ZZFC004CAR-018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗