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

NCT03778814 | Recruiting Phase 1

• 1 other identifier: ZZTCRT-006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nonsmall Cell Lung Cancer; Solid Tumor, Adult

Keywords

Lung Cancer; Solid Tumor; Immunotherapy; TCR-T Cell Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Dose Limiting Toxicity

  A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the TCR-T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.

  three months

Secondary Outcomes (1)

• Percent of Patients with best response as either complete remission or partial remission

  three months

Other Outcomes (1)

• Median TCR-T cell persistence

  Five years

Study Arms (1)

TCR-T cell therapy group

EXPERIMENTAL

Appropriate lung cancer or other solid tumor patients who could benefit from immunotherapy will be treated with targeting TCR-T cells.

Biological: TCR-T cells

Interventions

TCR-T cells BIOLOGICAL

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

TCR-T cell therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• Had accepted gene therapy before;
• Tumor size more than 25cm;
• Severe virus infection such as HBV, HCV, HIV, et al
• Known HIV positivity
• History of lung transplantation
• Active infectious disease related to bacteria, virus,fungi,et al
• Other severe diseases that the investigators consider not appropriate;
• Pregnant or lactating women
• Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
• Other conditions that the investigators consider not appropriate.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead
• Tcell Immune (Guangzhou) Science and Technology Ltd.: collaborator

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, 51260, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhenfeng Zhang, MD,PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD,PhD

CONTACT

0086-020-34153532; zhangzhf@gzhmu.edu.cn

Liangping Li, MD,PhD

CONTACT

020-38688609; liangping_li@jnu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 19, 2018
• Study Start: December 1, 2018
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2036
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

CN (1)