Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT03778814

TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors

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

30

Participants Needed

1

Research Sites

943 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital of Guangzhou Medical University

Lead Sponsor

T

Tcell Immune (Guangzhou) Science and Technology Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Tumor organoids and TILs (and/or peripheral T cells) cultures will be established from fresh tissure of lung cancer and other solid tumors. Coculture will be utilized to screen tumor-responsive T cells which are further selected for monoclonal expansion and TCR cloning for engineered reconstitution of TCR-T cells. After verification by multiple in vitro and in vivo studies, a large number of TCR-T cells will be introduced back into the patients via vein, artery or fine needle punctured to the tumor, or combinations. In this phase I study, the safety, tolerance and preliminary efficacy of the TCR-T cell immunotherapy on human will firstly be assessed.

CONDITIONS

Official Title

TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with advanced lung tumor or other solid tumor where biopsy is obtainable
  • Life expectancy greater than 12 weeks
  • Child-Pugh-Turcotte score less than 7
  • Adequate heart, lung, liver, and kidney function
  • Available autologous transduced T cells with ≥20% expression of targeted TCR sequences by flow-cytometry and ≥20% tumor cell killing in cytotoxicity assay
  • Informed consent explained, understood, and signed by patient or guardian with copy given
Not Eligible

You will not qualify if you...

  • Prior gene therapy
  • Tumor size larger than 25 cm
  • Severe viral infections such as HBV, HCV, HIV
  • Known HIV positivity
  • History of lung transplantation
  • Active infectious disease from bacteria, virus, fungi, etc.
  • Other severe diseases deemed inappropriate by investigators
  • Pregnant or lactating women
  • Systemic steroid treatment ≥0.5 mg prednisone equivalent/kg/day
  • Other conditions deemed inappropriate 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

Guanzhou, Guangdong, China, 51260

Actively Recruiting

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Research Team

Z

Zhenfeng Zhang, MD,PhD

CONTACT

L

Liangping Li, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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