NCT03778814RecruitingPhase 1
TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors
TCR-T Cells Targeting Cancer Cells for Immunotherapy of Lung Cancer and Other Solid Tumors: Phase I Clinical Trial
Source: ClinicalTrials.gov · Last updated 25 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 Dec 2018
- Start date
- 1 Dec 2018
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT03778814
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 1 Dec 2018 to the primary completion date, 30 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had accepted gene therapy before;
- Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
Other illness
- Severe virus infection such as HBV, HCV, HIV, et al
- Known HIV positivity
- History of lung transplantation
- Active infectious disease related to bacteria, virus,fungi,et al
- Other severe diseases that the investigators consider not appropriate;
- Other conditions that the investigators consider not appropriate.
Other
- Tumor size more than 25cm;
- Pregnant or lactating women
Who the study is looking for
- patients with advanced lung tumor or other solid tumor where biopsy is obtainable
- Life expectancy \>12 weeks
- Child-Pugh-Turcotte score \<7
- Adequate heart,lung,liver,kidney function
- 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
- Informed consent explained to, understood by and signed by patient/ guardian. Patient/guardian given copy of informed consent. -
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guanzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.