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TerminatedNCT03407040Updated Nov 10, 2021

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

An observational study in Gastrointestinal Cancers, Breast Cancer and Pancreatic Cancer, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2021-11-10.

Sponsored by National Cancer Institute (NCI) · Observational

Why this study was terminated
Investigator left NIH
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
98
Ages
15 Years and older
Sex
All
01

Study 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.

...

Read the detailed description

Background:

T-cells are potentially curative for patients with metastatic cancer, but many patients with cancer have T-cells that are terminally differentiated , a condition associated with treatment failure. We have observed that less differentiated T-cells have a greater capacity to proliferate, persist, and destroy large cancer deposits. Advances in regenerative medicine might allow the generation of rejuvenated T-cells from induced pluripotent stem cells (iPSC).

Objectives:

To reprogram patient specimens into induced pluripotent stem cells (iPSC) and differentiate them into different types of somatic cells with the goal to produce cancer antigen-specific T-cells.

To make stored specimens and/or data available to approved research laboratories and investigators.

Eligibility:

Patients enrolled on the National Cancer Institute Surgery Branch (NCI-SB) Cell Harvest protocol 03-C-0277 (Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols).

Patients willing to be consented on this protocol.

Design:

Cells and tissue obtained previously under protocol 03-C-2077.

Reprogramming of cells and tissue into iPSC lines.

Derivation of iPSC lines into T-cells and iPSC progeny capable of supporting T-cell differentiation.

Generation of an iPSC-derived thymic organoid.

Screening of tumor antigen specificity for regenerated T-cells.

In vivo analysis of regenerated T-cells.

02

Conditions studied

  • Gastrointestinal Cancers
  • Breast Cancer
  • Pancreatic Cancer
  • Melanoma
  • Lung Cancer

Keywords

  • Blood
  • Tissue
  • Immunotherapy
  • Tumor
  • Somatic
03

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

EXCLUSION CRITERIA:

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

04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
98 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1/Cancer Patients

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Approximately 10 years

  2. Availability of stored specimens and/or data

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

    Time frame: Approximately 10 years

06

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • 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. PubMed 23290140 ↗
  • 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. PubMed 23290135 ↗
  • 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. PubMed 23684540 ↗
08

Registry details

Key details

Study ID
NCT03407040
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Jan 30, 2018
Primary completion
Aug 27, 2019
Completion
Sep 30, 2019
Last update
Nov 10, 2021

Study contacts

Steven A Rosenberg, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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