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

Primary Purpose

Nonsmall Cell Lung Cancer, Solid Tumor, Adult

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TCR-T cells
Sponsored by
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonsmall Cell Lung Cancer focused on measuring Lung Cancer; Solid Tumor, Immunotherapy, TCR-T Cell Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TCR-T cell therapy group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2018
Last Updated
February 12, 2023
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Collaborators
Tcell Immune (Guangzhou) Science and Technology Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03778814
Brief Title
TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors
Official Title
TCR-T Cells Targeting Cancer Cells for Immunotherapy of Lung Cancer and Other Solid Tumors: Phase I Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Collaborators
Tcell Immune (Guangzhou) Science and Technology Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsmall Cell Lung Cancer, Solid Tumor, Adult
Keywords
Lung Cancer; Solid Tumor, Immunotherapy, TCR-T Cell Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TCR-T cell therapy group
Arm Type
Experimental
Arm Description
Appropriate lung cancer or other solid tumor patients who could benefit from immunotherapy will be treated with targeting TCR-T cells.
Intervention Type
Biological
Intervention Name(s)
TCR-T cells
Intervention Description
Engineering TCR-T cells targeting lung tumor and other solid tumor will be transfused back the patients.
Primary Outcome Measure Information:
Title
Number of Patients with Dose Limiting Toxicity
Description
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.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Percent of Patients with best response as either complete remission or partial remission
Description
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.
Time Frame
three months
Other Pre-specified Outcome Measures:
Title
Median TCR-T cell persistence
Description
Median TCR-T cell persistence will be measured by quantitative rt-PCR.
Time Frame
Five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenfeng Zhang, MD,PhD
Phone
0086-020-34153532
Email
zhangzhf@gzhmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Liangping Li, MD,PhD
Phone
020-38688609
Email
liangping_li@jnu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenfeng Zhang, MD,PhD
Organizational Affiliation
Second Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
51260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenfeng Zhang, MD,PhD
Phone
02034153532
Email
zhangzhf@gzhmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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