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Intervention of Engineered Immune Effector T Cells Against Lung Cancer

Primary Purpose

Lung Cancer, NSCLC

Status

Withdrawn

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

LC-CTLs

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer, Cytotoxic lymphocyte, LC-CTL, NSCLC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written, informed consent obtained prior to any study-specific procedures.
Age older than 18 years.
Patients with refractory, relapsed, metastatic, advanced lung cancer confirmed by histology and biopsy.
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
Expected survival ≥ 12 weeks.
Not pregnant, and on appropriate birth control if of childbearing potential.
Initial hematopoietic reconstitution with
- neutrophils (ANC) ≥ 1,000/mm^3;
- platelet (PLT) ≥ 100,000/mm^3.
Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
- serum creatinine ≤ 2×ULN;
- serum bilirubin ≤ 2×ULN;
- AST/ALT ≤ 2×ULN;
- ALKP ≤ 5×ULN;
- serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test were negative.

Exclusion Criteria:

Have occurred in 5 years or are currently suffering from other cancers, except for cured cervical cancer, non-melanoma skin cancer and superficial bladder cancer.
Previous exposure to mouse CEA antibody.
Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
Pregnant or lactating females.
Inadequate bone marrow function with
- absolute neutrophil count < 1,000/mm^3;
- platelet count < 100,000/mm^3;
- Hb < 9 g/dL.
Inadequate liver and renal function with
- serum (total) bilirubin > 1.5 x ULN;
- AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases);
- alkaline phosphatase > 2.5 x ULN;
- serum creatinine >2.0 mg/dl (> 177 μmol/L);
- urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.
Serious active infection requiring i.v. antibiotics at during screening.
Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.

Sites / Locations

Shenzhen Geno-immune Medical Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LC-CTLs

Arm Description

Autologous lung cancer specific cytotoxic lymphocytes

Outcomes

Primary Outcome Measures

Safety of LC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

Physiological parameter (measuring cytokine response)

Secondary Outcome Measures

Functional analyses of LC-CTLs in vitro

The specificity of LC-CTLs in vitro will be analysed by intracellular cytokine staining (ICCS) or enzyme-linked immunospot assay (ELISPOT).

Anti-tumor effects

Biochemical markers and image scan will be got before and after treatment. 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

NCT03353428

First Posted

November 20, 2017

Last Updated

March 25, 2018

Sponsor

Shenzhen Geno-Immune Medical Institute

1. Study Identification

Unique Protocol Identification Number

NCT03353428

Brief Title

Intervention of Engineered Immune Effector T Cells Against Lung Cancer

Official Title

Interventional Treatment of Lung Cancer (LC) With LC Specific Immune Lymphocytes (LC-CTLs)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Withdrawn

Why Stopped

combine with NCT03356808

Study Start Date

November 15, 2017 (Actual)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

December 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 primary objective of this study is to evaluate the safety of lung cancer specific cytotoxic lymphocytes (LC-CTLs). The secondary objectives are to evaluate the rate of successful LC-CTLs generation in vitro and determine the anti-lung cancer efficacy.

Detailed Description

Lung cancer is a malignant lung tumor characterized by uncontrolled cell growth in tissues of the lung. The two main types are small-cell lung carcinoma (SCLC) and non-small-cell lung carcinoma (NSCLC). Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths. Common treatments include surgery, chemotherapy, and radiotherapy. Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of lung cancer specific cytotoxic T lymphocytes cells in patients.

6. Conditions and Keywords

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

Lung Cancer, NSCLC

Keywords

Lung cancer, Cytotoxic lymphocyte, LC-CTL, NSCLC

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

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LC-CTLs

Arm Type

Experimental

Arm Description

Autologous lung cancer specific cytotoxic lymphocytes

Intervention Type

Biological

Intervention Name(s)

LC-CTLs

Intervention Description

2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg via IV, chest or tumor injection each time

Primary Outcome Measure Information:

Title

Safety of LC-CTLs 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

Functional analyses of LC-CTLs in vitro

Description

The specificity of LC-CTLs in vitro will be analysed by intracellular cytokine staining (ICCS) or enzyme-linked immunospot assay (ELISPOT).

Time Frame

2 weeks

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

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written, informed consent obtained prior to any study-specific procedures. Age older than 18 years. Patients with refractory, relapsed, metastatic, advanced lung cancer confirmed by histology and biopsy. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. Expected survival ≥ 12 weeks. Not pregnant, and on appropriate birth control if of childbearing potential. Initial hematopoietic reconstitution with neutrophils (ANC) ≥ 1,000/mm^3; platelet (PLT) ≥ 100,000/mm^3. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with serum creatinine ≤ 2×ULN; serum bilirubin ≤ 2×ULN; AST/ALT ≤ 2×ULN; ALKP ≤ 5×ULN; serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome. Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test were negative. Exclusion Criteria: Have occurred in 5 years or are currently suffering from other cancers, except for cured cervical cancer, non-melanoma skin cancer and superficial bladder cancer. Previous exposure to mouse CEA antibody. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations). Pregnant or lactating females. Inadequate bone marrow function with absolute neutrophil count < 1,000/mm^3; platelet count < 100,000/mm^3; Hb < 9 g/dL. Inadequate liver and renal function with serum (total) bilirubin > 1.5 x ULN; AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases); alkaline phosphatase > 2.5 x ULN; serum creatinine >2.0 mg/dl (> 177 μmol/L); urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr. Serious active infection requiring i.v. antibiotics at during screening. Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.

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

Facility Information:

Facility Name

Shenzhen Geno-immune Medical Institute

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Intervention of Engineered Immune Effector T Cells Against Lung Cancer

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