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Published on: February 17, 2022
The Landscape of Clinical Trials for TCR-T Cell Therapy
Xingcan Fan1,2,3,4, Tao Yu5, Qiuyu Liao1,2,3,4
1Department of General Surgery.
Abstract:
T cell receptor-engineered T cell (TCR-T) therapy represents an innovative tumor immunotherapy. Distinct from CAR-T, it recognizes MHC-restricted antigens to target tumor-specific antigens, exhibiting unique advantages for both solid and hematologic malignancies. To clarify the main trends, key targets, and therapeutic indications of TCR-T therapy, this study systematically summarizes the landscape of TCR-T-targeted clinical trials based on rigorous screening of the Trialtrove database, including 260 trials before April 1, 2026. Descriptive statistics were used to analyze the trials in terms of phase, status, distribution, disease indications, primary targets, and investigational drugs. Overall, TCR-T clinical research maintains sustained enthusiasm, dominated by early-phase trials (phase I and phase I/II, accounting for 88.85%), with active trials (open and planned) accounting for 51.92% and a considerable proportion of terminated trials (21.92%). Geographically, trials are concentrated in the United States and China, which serve as core collaboration nodes, with obvious geographical clustering characteristics in regional collaboration networks. In terms of disease indications, TCR-T therapy is more focused on solid tumors, with unspecified solid tumor, non-small cell lung cancer, and head/neck cancer as the top 3 indications. NY-ESO-1 is the most prominent target, followed by MAGE-A4, KRAS, PRAME, HPV16 E6/E7, and HBV surface antigen, with letetresgene autoleucel and LioCyx-M004 being the most investigated TCR-T products. Collectively, TCR-T therapy is a promising field in tumor immunotherapy with continuous research investment and advancing clinical progress.
Insights
T cell receptor-engineered T cell (TCR-T) therapy shows promise for solid tumors, with ongoing early-phase clinical trials focusing on targets like NY-ESO-1. Research is concentrated in the US and China, indicating sustained enthusiasm for this innovative cancer immunotherapy.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- T cell receptor-engineered T cell (TCR-T) therapy is an emerging tumor immunotherapy distinct from CAR-T.
- It targets MHC-restricted tumor-specific antigens, offering potential for solid and hematologic malignancies.
Purpose of the Study:
- To systematically analyze the trends, targets, and indications of TCR-T therapy clinical trials.
- To provide an overview of the current landscape and future directions of TCR-T research.
Main Methods:
- Systematic screening of the Trialtrove database for TCR-T clinical trials up to April 1, 2026.
- Descriptive statistical analysis of trial phase, status, geographical distribution, disease indications, targets, and drugs.
Main Results:
- Sustained research enthusiasm is evident, with 88.85% in early phases (I/I-II) and 51.92% active trials.
- Trials are geographically concentrated in the US and China, with a focus on solid tumors (unspecified, NSCLC, head/neck cancer).
- NY-ESO-1 is the primary target, followed by MAGE-A4, KRAS, PRAME, HPV16 E6/E7, and HBV surface antigen; letetresgene autoleucel and LioCyx-M004 are key investigational products.
Conclusions:
- TCR-T therapy is a promising field in tumor immunotherapy with ongoing clinical progress.
- Continuous research investment and advancing clinical development highlight its potential in treating various cancers.
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