CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 30 target
Drug / intervention
TCR-T cellsbiological
Likely dose
Not stated in record
Key inclusion· 6
  • Advanced lung cancer or other solid tumor where biopsy is obtainable
  • Life expectancy greater than 12 weeks
  • Child-Pugh-Turcotte score less than 7
  • Adequate cardiac, pulmonary, hepatic, and renal function
Key exclusion· 10
  • Prior gene therapy
  • Tumor size greater than 25 cm
  • Severe viral infection (HBV, HCV, HIV)
  • Known HIV positive

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03778814
NCT03778814Phase 1RecruitingOn TrackUpdated 24mo ago
Long Recruiting

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

Second Affiliated Hospital of Guangzhou Medical University·interventional·Posted Dec 19, 2018·Updated Jun 25, 2024

In Brief

A Phase 1 clinical trial evaluating TCR-T cells for Nonsmall Cell Lung Cancer and Solid Tumor, Adult. Currently recruiting, targeting 30 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 1Recruiting
2019202020212022202320242025202620272028202920302031203220332034203520362037
First PostedDec 19, 2018
Enrollment StartDec 1, 2018
Primary CompletionDec 30, 2029
Study CompletionDec 30, 2036
TodayJul 1, 2026
Enrollment to primary: 11.1 yearsPosted 7.5 years agoPrimary completion in 3.5 years

Interventions

TCR-T cellsbiological

Engineering TCR-T cells targeting lung tumor and other solid tumor will be transfused back the patients.