Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, China, 51260
Actively Recruiting
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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