Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT05779917

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

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25

30

Participants Needed

1

Research Sites

678 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital of Guangzhou Medical University

Lead Sponsor

F

Fapon Biotherapy Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with advanced cancer that expresses Mesothelin protein
  • Life expectancy greater than 12 weeks
  • Adequate heart, lung, liver, kidney, and blood function
  • Availability of autologous transduced T cells with at least 20% Mesothelin-CAR expression by flow cytometry and at least 20% killing activity against Mesothelin-positive targets in cytotoxicity assay
  • Signed informed consent by patient or guardian with understanding and explanation provided
Not Eligible

You will not qualify if you...

  • Prior gene therapy treatment
  • Severe viral infections such as HBV, HCV, or HIV
  • Known HIV positivity
  • Active infectious diseases caused by bacteria, viruses, fungi, or other pathogens
  • Other severe illnesses deemed inappropriate by investigators
  • Pregnant or breastfeeding women
  • Systemic steroid treatment equal to or greater than 0.5 mg prednisone equivalent per kg per day
  • Other conditions considered unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510260

Actively Recruiting

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Research Team

Z

Zhenfeng Zhang, MD, PhD

CONTACT

B

Bingjia He, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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