NCT03778814

TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors

Recruiting now Phase 1 Last updated 25 June 2024

What this trial tests

Phase 1 trial testing TCR-T cells in Nonsmall Cell Lung Cancer in 30 participants. Currently enrolling.

Timeline

1 December 2018

Primary endpoint
30 December 2029

30 December 2036

Quick facts

Lead sponsor	Second Affiliated Hospital of Guangzhou Medical University
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 December 2018
Primary completion	30 December 2029
Estimated completion	30 December 2036
Sites	1 location across China

Drugs / interventions tested

• TCR-T cells

Conditions studied

• Nonsmall Cell Lung Cancer — all drugs for Nonsmall Cell Lung Cancer →
• Solid Tumor, Adult — all drugs for Solid Tumor, Adult →

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Who can join

Adults 18 to 75, any sex, with Nonsmall Cell Lung Cancer or Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. TCR-engineered T cell therapy in solid tumors: State of the art and perspectives.
   Baulu E, Gardet C, Chuvin N, Depil S. · · 2023 · cited 283× · PMID 36791198 · DOI 10.1126/sciadv.adf3700
2. Human disease models in drug development.
   Loewa A, Feng JJ, Hedtrich S. · · 2023 · cited 164× · PMID 37359774 · DOI 10.1038/s44222-023-00063-3
3. 3D Tumor Models and Their Use for the Testing of Immunotherapies.
   Boucherit N, Gorvel L, Olive D. · · 2020 · cited 130× · PMID 33362787 · DOI 10.3389/fimmu.2020.603640
4. Emerging organoid models: leaping forward in cancer research.
   Fan H, Demirci U, Chen P. · · 2019 · cited 124× · PMID 31884964 · DOI 10.1186/s13045-019-0832-4
5. Adoptive cellular immunotherapy for solid neoplasms beyond CAR-T.
   Liu Q, Li J, Zheng H, Yang S, et al · · 2023 · cited 102× · PMID 36750830 · DOI 10.1186/s12943-023-01735-9
6. Insights Into Lung Cancer Immune-Based Biology, Prevention, and Treatment.
   Saab S, Zalzale H, Rahal Z, Khalifeh Y, et al · · 2020 · cited 79× · PMID 32117295 · DOI 10.3389/fimmu.2020.00159
7. T Cell Based Immunotherapy for Cancer: Approaches and Strategies.
   Want MY, Bashir Z, Najar RA. · · 2023 · cited 44× · PMID 37112747 · DOI 10.3390/vaccines11040835
8. Organoids: development and applications in disease models, drug discovery, precision medicine, and regenerative medicine.
   Yao Q, Cheng S, Pan Q, Yu J, et al · · 2024 · cited 40× · PMID 39309690 · DOI 10.1002/mco2.735