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Antigen-specific T Cells Against Lung Cancer

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Lung cancer-specific T cells

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer, CAR-T, mesothelin, Muc1, GD2, MAGE-A4

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with stage III, IV or relapsed lung cancer confirmed by histology and biopsy.
Age: ≥ 18 years and ≤ 80 years.
4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
Side Effects of Chemotherapy have subsided.
Cancer specific antigens are identified and shown to express at high levels (>2+) in malignant tissues by immuno-histochemical staining or flow cytometry.
Karnofsky/Lansky ≥ 50%.
Expected survival ≥ 6 weeks.

Initial hematopoietic conditions with

neutrophils (ANC) ≥ 1×10^6/L;
platelet (PLT) ≥ 1×10^8/L.

Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with

serum creatinine ≤ 2×ULN;
serum bilirubin ≤ 3×ULN;
AST/ALT ≤ 5×ULN.
10. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures.

Exclusion Criteria:

Airway obstruction caused by tumor.
History of epilepsy or other central nervous system diseases.
Patients who require systemic corticosteroid or other immunosuppressive therapy.
History of prolonged or serious heart disease during QT.
history of serious cyclophosphamide toxicity.
Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in any immune cell therapy study.

Inadequate liver and renal function with

serum creatinine > 2.5 mg/dl;
serum (total) bilirubin > 2.0 mg/dl;
AST & ALT > 3 x ULN.
8. Pregnant or lactating females. 9. Serious active infection during screening. 10. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
11. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Sites / Locations

Jinshazhou Hospital of Guangzhou University of Chinese MedicineRecruiting
Shenzhen Geno-immune Medical InstituteRecruiting
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lung cancer-specific T cells

Arm Description

Peripheral blood mononuclear cells (PBMCs) of patients, who have cancer antigen identified lung cancer, will be obtained through apheresis, and T cells will be activated and ex vivo engineered.

Outcomes

Primary Outcome Measures

Safety of engineered T cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

Physiological parameter (measuring cytokine response)

Secondary Outcome Measures

Persistence and proliferation of engineered antigen-specific T cells in patients

The expansion and functional persistence of ex vivo engineered T cells in the peripheral blood of patients will be examined on Day 7, 14, 21, 28, 60 and 90 after infusion.

Anti-tumor effects

Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Full Information

NCT ID

NCT03356808

First Posted

November 24, 2017

Last Updated

September 18, 2019

Sponsor

Shenzhen Geno-Immune Medical Institute

1. Study Identification

Unique Protocol Identification Number

NCT03356808

Brief Title

Antigen-specific T Cells Against Lung Cancer

Official Title

Multicenter Trial of Cancer Antigen-specific T Cells in the Treatment of Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 15, 2017 (Actual)

Primary Completion Date

January 1, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shenzhen Geno-Immune Medical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of cancer antigen-specific T cells targeting lung cancer. The cancer targeting antigens are identified through immunostaining of patient's cancer specimens. Another goal of the study is to learn more about the persistence and function of the ex vivo manipulated antigen-specific T cells in the body.

Detailed Description

Lung cancer is a malignancy characterized by uncontrolled cell growth in tissues of the lung. There are two main types of lung cancer, small-cell lung carcinoma (SCLC) and non-small-cell lung carcinoma (NSCLC). In 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths worldwide. Common treatments include surgery, chemotherapy, and radiotherapy, but in relapsed cancer patients, such treatments often have limited successes. In this study, the participant's peripheral blood mononuclear cells will be collected for antigen-specific T cell preparation, and/or modified using an advanced lentiviral vector system. Then the antigen-specific T cells, called engineered immune effectors (EIEs) or chimeric antigen receptor modified-T cells (CAR T), which can recognize specific molecules that are expressed by the lung cancer cells, are given back to the participant by intravenous infusion. The purpose of this clinical trial is to assess the feasibility, safety and efficacy of T cell immunotherapy targeting single or multiple cancer antigens. The lung cancer antigens include known tumor antigens such as MAGE-A1, MAGE-A4, MucI, GD2, and mesothelin, as well as novel cancer antigens. Another goal of the study is to learn more about the persistence and function of the specific CAR T cells in the body.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Lung cancer, CAR-T, mesothelin, Muc1, GD2, MAGE-A4

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lung cancer-specific T cells

Arm Type

Experimental

Arm Description

Peripheral blood mononuclear cells (PBMCs) of patients, who have cancer antigen identified lung cancer, will be obtained through apheresis, and T cells will be activated and ex vivo engineered.

Intervention Type

Biological

Intervention Name(s)

Lung cancer-specific T cells

Intervention Description

1 infusion, for 1x10^6~1x10^7 cells/kg via IV

Primary Outcome Measure Information:

Title

Safety of engineered T cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

Description

Physiological parameter (measuring cytokine response)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Persistence and proliferation of engineered antigen-specific T cells in patients

Description

The expansion and functional persistence of ex vivo engineered T cells in the peripheral blood of patients will be examined on Day 7, 14, 21, 28, 60 and 90 after infusion.

Time Frame

3 months

Title

Anti-tumor effects

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with stage III, IV or relapsed lung cancer confirmed by histology and biopsy. Age: ≥ 18 years and ≤ 80 years. 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy. Side Effects of Chemotherapy have subsided. Cancer specific antigens are identified and shown to express at high levels (>2+) in malignant tissues by immuno-histochemical staining or flow cytometry. Karnofsky/Lansky ≥ 50%. Expected survival ≥ 6 weeks. Initial hematopoietic conditions with neutrophils (ANC) ≥ 1×10^6/L; platelet (PLT) ≥ 1×10^8/L. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with serum creatinine ≤ 2×ULN; serum bilirubin ≤ 3×ULN; AST/ALT ≤ 5×ULN. 10. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures. Exclusion Criteria: Airway obstruction caused by tumor. History of epilepsy or other central nervous system diseases. Patients who require systemic corticosteroid or other immunosuppressive therapy. History of prolonged or serious heart disease during QT. history of serious cyclophosphamide toxicity. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in any immune cell therapy study. Inadequate liver and renal function with serum creatinine > 2.5 mg/dl; serum (total) bilirubin > 2.0 mg/dl; AST & ALT > 3 x ULN. 8. Pregnant or lactating females. 9. Serious active infection during screening. 10. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection. 11. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lung-Ji Chang, PhD

Phone

86-075586725195

c@szgimi.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lung-Ji Chang, PhD

Organizational Affiliation

Shenzhen Geno-Immune Medical Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Qichun Cai, MD

Organizational Affiliation

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Xun Lai, MD

Organizational Affiliation

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

Official's Role

Study Director

Facility Information:

Facility Name

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510415

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qichun Cai, MD

Phone

86-13802830754

Facility Name

Shenzhen Geno-immune Medical Institute

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lung-Ji Chang, PhD

Phone

86-075586725195

c@szgimi.org

Facility Name

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xun Lai, MD

Phone

13577096609

1729112214@qq.com

12. IPD Sharing Statement

Plan to Share IPD

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Antigen-specific T Cells Against Lung Cancer

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