Generation of Cancer Antigen-Specific T-cells From Human Induced Pluripotent Stem Cells (iPSC) for Research and Potential FutureTherapy

NCT03407040 | Terminated

• 2 other identifiers: 18004318-C-0043
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Researchers want to test if certain cells can be re-programmed into stem cells. Stem cells can keep reproducing for a long time. Cells made by stem cells can be turned into different types of cells. These include cancer-fighting cells, skin cells, etc. The stem cells generated in this study will be used to make specific tumor-fighting cells that can recognize different types of mutations in cancer cells. They may also help identify new tumor mutations that may not have been identified yet. Objectives: To test if a certain type of tumor-fighting cells can be re-programmed into stem cells. Eligibility: Participants in another Surgery Branch protocol who are at least 16 years old Design: Participants already gave samples of blood and/or tumor tissue in the other protocol. They do not need to come back to the clinic or give any other samples. Participants will give consent for their samples to be used in this study. Researchers will obtain cells from the samples. They will grow those cells in the lab. They will create stem cells from them. Researchers will do genetic tests on the samples. Most tests will not show important health results. But if they do, the participant will be invited to talk to a genetic counselor and get more detailed testing to confirm the results. Some of the samples and results will be stored indefinitely. They may be used in future research. No personal information will be stored with them. ...

Conditions

Gastrointestinal Cancers; Breast Cancer; Pancreatic Cancer; Melanoma; Lung Cancer

Keywords

Blood; Tissue; Immunotherapy; Tumor; Somatic

Outcome Measures

Primary Outcomes (2)

• Production of cancer antigen-specific T-cells

  Reprogram patient specimens into induced pluripotent stem cells (iPSC) and differentiate them into different types of somatic cells

  Approximately 10 years

• Availability of stored specimens and/or data

  Availability of stored specimens and/or data to approved research laboratories and investigators

  Approximately 10 years

Study Arms (1)

1/Cancer Patients

Patients with a cancer diagnosis enrolled on protocol 03-C-0277

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a cancer diagnosis enrolled on protocol 03-C-0277

You may qualify if:

• Patients with a cancer diagnosis enrolled on protocol 03-C-0277.
• Willing and able to provide informed consent
• Patients must be greater than or equal to 15 years of age.

You may not qualify if:

• Healthy donors enrolled on protocol 03-C-0277.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Nishimura T, Kaneko S, Kawana-Tachikawa A, Tajima Y, Goto H, Zhu D, Nakayama-Hosoya K, Iriguchi S, Uemura Y, Shimizu T, Takayama N, Yamada D, Nishimura K, Ohtaka M, Watanabe N, Takahashi S, Iwamoto A, Koseki H, Nakanishi M, Eto K, Nakauchi H. Generation of rejuvenated antigen-specific T cells by reprogramming to pluripotency and redifferentiation. Cell Stem Cell. 2013 Jan 3;12(1):114-26. doi: 10.1016/j.stem.2012.11.002.

  PMID: 23290140 BACKGROUND

• Vizcardo R, Masuda K, Yamada D, Ikawa T, Shimizu K, Fujii S, Koseki H, Kawamoto H. Regeneration of human tumor antigen-specific T cells from iPSCs derived from mature CD8(+) T cells. Cell Stem Cell. 2013 Jan 3;12(1):31-6. doi: 10.1016/j.stem.2012.12.006.

  PMID: 23290135 BACKGROUND

• Parent AV, Russ HA, Khan IS, LaFlam TN, Metzger TC, Anderson MS, Hebrok M. Generation of functional thymic epithelium from human embryonic stem cells that supports host T cell development. Cell Stem Cell. 2013 Aug 1;13(2):219-29. doi: 10.1016/j.stem.2013.04.004. Epub 2013 May 16.

  PMID: 23684540 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood lymphocytes, tumor-infiltrating lymphocytes, tissue

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Melanoma; Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steven A Rosenberg, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2018
• First Posted: January 23, 2018
• Study Start: January 30, 2018
• Primary Completion: August 27, 2019
• Study Completion: September 30, 2019
• Last Updated: November 10, 2021

Record last verified: 2021-11

Locations

US (1)