Clinical Trials Logo
  1. Home
  2. Solid Tumor, Adult
  3. NCT03778814

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

Solid Tumor, Adult Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

1. Choose appropriate patients with KK-LC-1 expression in advanced lung cancer or other solid tumors and matched MHC-A11 typing, with written consent for this study; For cancer without expression of KK-LC-1, fresh tumor tissue should be obtained for RNA/DNA sequencing to computationally identify neoantigen peptides that can be captured by specifically personizedly synthesized poly-MHCI which can be further used to fish appropriate T cells from the patient. 2. Perform biopsy to obtain tissue from tumor/lymph node for organoids, TILs, DC and T cells culture, coculture to screening anti-tumor T cells, establish and select monoclonal T cells for TCR cloning; 3. Clone TCR sequence that targets KK-LC-1 or neoantigens; collect PBMCs from the blood of the patients, isolate and activate the T cells and generate the TCR-T cells; 4. Test the quality and killing activity of the TCR-T cells in vitro and then transplant back the patients via systemic (vein and/or artery) or local injections, and follow up closely to collect related clinical data as needed; 5. Evaluate the clinical results as needed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03778814
Study type Interventional
Source Second Affiliated Hospital of Guangzhou Medical University
Contact Zhenfeng Zhang, MD,PhD
Phone 0086-020-34153532
Email zhangzhf@gzhmu.edu.cn
Status Recruiting
Phase Phase 1
Start date December 1, 2018
Completion date December 30, 2033
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04551885 - FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors Phase 1
Completed NCT05054348 - First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Recruiting NCT06088004 - Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05055609 - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors Phase 1
Completed NCT04020185 - Safety and Efficacy Study of IMSA101 in Refractory Malignancies Phase 1/Phase 2
Withdrawn NCT05071846 - MVX-ONCO-2 in Advanced Solid Tumors Phase 1
Recruiting NCT05607199 - A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics Phase 1
Active, not recruiting NCT04552288 - Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies Phase 2
Active, not recruiting NCT06026254 - A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial Phase 1
Recruiting NCT06144671 - GT201 Injection For The Treatment Of Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06032845 - Cryoablation Combined With Tislelizumab Plus Lenvatinib In Previously Treated Solid Tumors (CASTLE-11) Phase 2
Not yet recruiting NCT06398418 - R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors Phase 1
Recruiting NCT05276284 - Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy Phase 1/Phase 2
Recruiting NCT04121442 - Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04221204 - A Monotherapy in Subjects With Advanced Solid Tumors Phase 1
Terminated NCT03992326 - Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors Phase 1
Terminated NCT05435339 - A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy Phase 1/Phase 2
Recruiting NCT04981119 - Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Recruiting NCT06075849 - Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent Phase 1