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

Who is this study for? Patients with Non-small Cell Lung Cancer, Solid Tumors
What treatments are being studied? TCR-T Cells
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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. -

Locations
Other Locations
China
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guanzhou
Contact Information
Primary
Zhenfeng Zhang, MD,PhD
zhangzhf@gzhmu.edu.cn
0086-020-34153532
Backup
Liangping Li, MD,PhD
liangping_li@jnu.edu.cn
020-38688609
Time Frame
Start Date: 2018-12-01
Estimated Completion Date: 2036-12-30
Participants
Target number of participants: 30
Treatments
Experimental: TCR-T cell therapy group
Appropriate lung cancer or other solid tumor patients who could benefit from immunotherapy will be treated with targeting TCR-T cells.
Sponsors
Leads: Second Affiliated Hospital of Guangzhou Medical University
Collaborators: Tcell Immune (Guangzhou) Science and Technology Ltd.

This content was sourced from clinicaltrials.gov