Tumor-specific T Cells in Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Tumor-specific Effector T Cells in Non-small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02515760
• Other study ID #: S-515/2013
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2014
• Est. completion date: September 2025

Study information

• Verified date: July 2023
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-small cell lung cancer is characterized by aggressive growth and treatment resistance. New approaches include immunotherapeutic strategies but spontaneous immune responses against tumor antigens remain unclear. The aim of this study is to characterize localization and frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: September 2025
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Patients with histology proven non-small cell lung cancer or a lesion suspicious of non-small cell lung cancer (lung cancer group)

• Healthy donors (control group)

• written informed consent

Exclusion Criteria:

• Autoimmune disease

• Patients receiving immunomodulatory drugs, e.g. tacrolimus

• Prior malignancy

• Pregnancy

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Procedure:
• Bone marrow aspiration from the iliac crest

Device:
• Illinois bone marrow aspiration neddle

Locations

Country	Name	City	State
Germany	Division of Thoracic Surgery, Technical University of Munich, Munich, Germany	Munich

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Heidelberg	German Cancer Research Center, Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Safi S, Yamauchi Y, Hoffmann H, Weichert W, Jost PJ, Winter H, Muley T, Beckhove P. Circulating Interleukin-4 Is Associated with a Systemic T Cell Response against Tumor-Associated Antigens in Treatment-Naive Patients with Resectable Non-Small-Cell Lung C — View Citation

Safi S, Yamauchi Y, Rathinasamy A, Stamova S, Eichhorn M, Warth A, Rauch G, Dienemann H, Hoffmann H, Beckhove P. Functional T cells targeting tumor-associated antigens are predictive for recurrence-free survival of patients with radically operated non-sma — View Citation

Safi S, Yamauchi Y, Stamova S, Rathinasamy A, Op den Winkel J, Junger S, Bucur M, Umansky L, Warth A, Herpel E, Eichhorn M, Winter H, Hoffmann H, Beckhove P. Bone marrow expands the repertoire of functional T cells targeting tumor-associated antigens in p — View Citation

Yamauchi Y, Safi S, Blattner C, Rathinasamy A, Umansky L, Juenger S, Warth A, Eichhorn M, Muley T, Herth FJF, Dienemann H, Platten M, Beckhove P, Utikal J, Hoffmann H, Umansky V. Circulating and Tumor Myeloid-derived Suppressor Cells in Resectable Non-Small Cell Lung Cancer. Am J Respir Crit Care Med. 2018 Sep 15;198(6):777-787. doi: 10.1164/rccm.201708-1707OC. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequencies of tumor-specific T cells	% of all T cells	2 weeks postoperative
Secondary	Tumor-specific T cells location determined by Enzyme Linked Immuno Spot Assay (ELISPOT) analysis of peripheral blood and bone marrow samples from the same patient	location: peripheral versus bone marrow	2 weeks postoperative
Secondary	Long-term survival	OS	5 years postoperative