Intervention of Engineered Immune Effector T Cells Against Lung Cancer

NCT ID: NCT03353428

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2020-12-31

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.

Conditions

Lung Cancer; NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LC-CTLs

Autologous lung cancer specific cytotoxic lymphocytes

Group Type: EXPERIMENTAL

LC-CTLs

Intervention Type: BIOLOGICAL

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

Interventions

LC-CTLs

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Written, informed consent obtained prior to any study-specific procedures.

2. Age older than 18 years.

3. Patients with refractory, relapsed, metastatic, advanced lung cancer confirmed by histology and biopsy.

4. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.

5. Expected survival ≥ 12 weeks.

6. Not pregnant, and on appropriate birth control if of childbearing potential.

7. Initial hematopoietic reconstitution with

• neutrophils (ANC) ≥ 1,000/mm^3;
• platelet (PLT) ≥ 100,000/mm^3.

8. 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.

9. Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test were negative.

Exclusion Criteria

1. 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.

2. Previous exposure to mouse CEA antibody.

3. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.

4. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).

5. Pregnant or lactating females.

6. Inadequate bone marrow function with

• absolute neutrophil count < 1,000/mm^3;
• platelet count < 100,000/mm^3;
• Hb < 9 g/dL.

7. 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.

8. Serious active infection requiring i.v. antibiotics at during screening.

9. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Geno-Immune Medical Institute

OTHER

Sponsor Role: lead

Responsible Party

Lung-Ji Chang

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lung-Ji Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Geno-Immune Medical Institute

Locations

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

Countries

China

Other Identifiers

GIMI-IRB-17022

Identifier Type: -

Identifier Source: org_study_id