TCR-T cell immunotherapy for lung cancer and solid tumors

TCR-T Cells Targeting Cancer Cells for Immunotherapy of Lung Cancer and Other Solid Tumors: Phase I Clinical Trial

This study is testing a new immunotherapy that uses specially modified T cells to see if it can help people with advanced lung cancer and other solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (Academic / other)
• Drugs / interventions: prednisone, immunotherapy
• Locations: 1 site (Guanzhou, Guangdong)
• Trial ID: NCT03778814 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on developing TCR-T cell immunotherapy for patients with advanced lung cancer and other solid tumors. It involves obtaining fresh tumor tissue to create organoids and culture tumor-infiltrating lymphocytes (TILs) or peripheral T cells. The study aims to identify and expand tumor-responsive T cells, which will be genetically engineered to target specific tumor antigens. The safety, tolerance, and preliminary efficacy of this therapy will be assessed through various administration methods, including systemic and local injections.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced lung tumors or other solid tumors who have a biopsy obtainable and express KK-LC-1 or have identifiable neoantigens.

Not a fit: Patients with a history of gene therapy, severe viral infections, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel and effective treatment option for patients with advanced lung cancer and other solid tumors.

How similar studies have performed: Other studies have shown promise with TCR-T cell therapies, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

1. patients with advanced lung tumor or other solid tumor where biopsy is obtainable
2. Life expectancy \>12 weeks
3. Child-Pugh-Turcotte score \<7
4. Adequate heart,lung,liver,kidney function
5. Available autologous transduced T cells with greater than or equal to 20% expression of targeted TCR sequences determined by flow-cytometry and killing of tumor cells greater than or equal to 20% in cytotoxicity assay
6. Informed consent explained to, understood by and signed by patient/ guardian. Patient/guardian given copy of informed consent. -

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Tumor size more than 25cm;
3. Severe virus infection such as HBV, HCV, HIV, et al
4. Known HIV positivity
5. History of lung transplantation
6. Active infectious disease related to bacteria, virus,fungi,et al
7. Other severe diseases that the investigators consider not appropriate;
8. Pregnant or lactating women
9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
10. Other conditions that the investigators consider not appropriate.

Where this trial is running

Guanzhou, Guangdong

• The Second Affiliated Hospital of Guangzhou Medical University — Guanzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Zhenfeng Zhang, MD,PhD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Zhenfeng Zhang, MD,PhD

Conditions Nonsmall Cell Lung Cancer; Solid Tumor, Adult; Lung Cancer; Solid Tumor; Immunotherapy; TCR-T Cell Therapy