Intervention of Engineered Immune Effector T Cells Against Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03353428
• Other study ID #: GIMI-IRB-17022
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: November 20, 2017
• Last updated: March 25, 2018
• Start date: November 15, 2017
• Est. completion date: December 2020

Study information

• Verified date: March 2018
• Source: Shenzhen Geno-Immune Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• NSCLC

Intervention

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

Locations

Country	Name	City	State
China	Shenzhen Geno-immune Medical Institute	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Geno-Immune Medical Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of LC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events	Physiological parameter (measuring cytokine response)	3 months
Secondary	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).	2 weeks
Secondary	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.	1 year