Antigen-specific T Cells Against Lung Cancer

NCT03356808 | Unknown Phase 1

• 1 other identifier: GIMI-IRB-17023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months

Secondary Outcomes (2)

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

  3 months

• Anti-tumor effects

  1 year

Study Arms (1)

Lung cancer-specific T cells

EXPERIMENTAL

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.

Biological: Lung cancer-specific T cells

Interventions

Lung cancer-specific T cells BIOLOGICAL

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

Lung cancer-specific T cells

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stage III, IV or relapsed lung cancer confirmed by histology and biopsy.
• Age: ≥ 18 years and ≤ 80 years.
• 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.
• \. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures.

You may not qualify if:

• 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.
• \. 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.
• \. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (3)

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510415, China

RECRUITING

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

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

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Medullary cystic kidney disease 1

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

• Qichun Cai, MD

  Jinshazhou Hospital of Guangzhou University of Chinese Medicine

  STUDY DIRECTOR

• Xun Lai, MD

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

  STUDY DIRECTOR

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

86-075586725195; c@szgimi.org

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 24, 2017
• First Posted: November 29, 2017
• Study Start: December 15, 2017
• Primary Completion: January 1, 2020
• Study Completion: December 31, 2020
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)