Intervention of Engineered Immune Effector T Cells Against Lung Cancer

NCT03353428 | Withdrawn Phase 1

• 1 other identifier: GIMI-IRB-17022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; NSCLC

Keywords

Lung cancer; Cytotoxic lymphocyte; LC-CTL; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Functional analyses of LC-CTLs in vitro

  2 weeks

• Anti-tumor effects

  1 year

Study Arms (1)

LC-CTLs

EXPERIMENTAL

Autologous lung cancer specific cytotoxic lymphocytes

Biological: LC-CTLs

Interventions

LC-CTLs BIOLOGICAL

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

LC-CTLs

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lung-Ji Chang, PhD

  Shenzhen Geno-Immune Medical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 27, 2017
• Study Start: November 15, 2017
• Primary Completion: January 1, 2019
• Study Completion: December 1, 2020
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)