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

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ClinicalTrials.gov Identifier: NCT03778814
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
First Affiliated Hospital of Jinan University
Information provided by (Responsible Party):
Second Affiliated Hospital of Guangzhou Medical University

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 tumor puncture, 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.

Condition or disease Intervention/treatment Phase
Nonsmall Cell Lung Cancer Solid Tumor, Adult Biological: TCR-T cells Phase 1

Detailed Description:
  1. Choose appropriate patients with advanced lung cancer or other solid tumors, with written consent for this study;
  2. Perform biopsy to obtain tissue for organoids and TILs, coculture to screening anti-tumor T cells, select monoclonal T cells;
  3. Clone TCR sequence; collect PBMCs from the blood of the patients, isolate and activate the T cells and produce TCR-T cells;
  4. Test the quality and killing activity of the TCR-T cells 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TCR-T Cells Targeting Cancer Cells for Immunotherapy of Lung Cancer and Other Solid Tumors: Phase I Clinical Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Biological: TCR-T cells
Engineering TCR-T cells targeting lung tumor and other solid tumor will be transfused back the patients.




Primary Outcome Measures :
  1. Number of Patients with Dose Limiting Toxicity [ Time Frame: three months ]
    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.


Secondary Outcome Measures :
  1. Percent of Patients with best response as either complete remission or partial remission [ Time Frame: three months ]
    Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.


Other Outcome Measures:
  1. Median TCR-T cell persistence [ Time Frame: Five years ]
    Median TCR-T cell persistence will be measured by quantitative rt-PCR.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients with advanced lung tumor or other solid tumor where biopsy is obtainable
  2. Life expectancy >12 weeks
  3. Child-Pugh-Turcotte score <7
  4. Adequate heart,lung,liver,kidney function
  5. 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
  6. Informed consent explained to, understood by and signed by patient/ guardian. Patient/guardian given copy of informed consent. -

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778814


Contacts
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Contact: Zhenfeng Zhang, MD,PhD 0086-020-34153532 zhangzhf@gzhmu.edu.cn
Contact: Liangping Li, MD,PhD 020-38688609 liangping_li@jnu.edu.cn

Locations
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China, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guanzhou, Guangdong, China, 51260
Contact: Zhenfeng Zhang, MD,PhD    02034153532    zhangzhf@gzhmu.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital of Guangzhou Medical University
First Affiliated Hospital of Jinan University
Investigators
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Principal Investigator: Zhenfeng Zhang, MD,PhD Second Affiliated Hospital of Guangzhou Medical University

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Responsible Party: Second Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03778814     History of Changes
Other Study ID Numbers: TCR-T therapy on solid tumor
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Second Affiliated Hospital of Guangzhou Medical University:
Lung Cancer; Solid Tumor
Immunotherapy
TCR-T Cell Therapy

Additional relevant MeSH terms:
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Immunologic Factors
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Physiological Effects of Drugs