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NCT Number: NCT03778814

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, 51260, China

Location status: Recruiting

Location contact

Zhenfeng Zhang, MD,PhD

CONTACT

[email protected]

02034153532

About this study

  • 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.
  • 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;
  • 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;
  • 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;
  • Evaluate the clinical results as needed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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. -

Exclusion criteria

  • 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.

Treatment and study plan

TCR-T cells

Biological

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

Primary outcomes

  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 outcomes

  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 outcomes

  1. Median TCR-T cell persistence

    Time frame: Five years

    Median TCR-T cell persistence will be measured by quantitative rt-PCR.

Study contacts

Contact information is provided by the study sponsor or research team.

Liangping Li, MD,PhD

CONTACT

[email protected]

020-38688609

Zhenfeng Zhang, MD,PhD

CONTACT

[email protected]

0086-020-34153532

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

  • Tcell Immune (Guangzhou) Science and Technology Ltd.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2029
Study completion
2036
First posted
Dec 19, 2018
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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