Gastrointestinal CancersNCT03407040
Generation of Cancer Antigen-Specific T-cells From Human Induced Pluripotent Stem Cells (iPSC) for Research and Potential FutureTherapy
An observational study of Gastrointestinal Cancers and Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Gastrointestinal Cancers, Breast Cancer, Pancreatic Cancer
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a cancer diagnosis enrolled on protocol 03-C-0277
Who may be able to join
- 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.
Who cannot join
- -Healthy donors enrolled on protocol 03-C-0277.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Generation of Cancer Antigen-Specific T-cells From Human Induced Pluripotent Stem Cells (iPSC) for Research and Potential Future Therapy
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.
Read more
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.
- Keywords
- Blood, Tissue, Immunotherapy, Tumor, Somatic
- Medical subject headings
- Gastrointestinal Neoplasms, Breast Neoplasms, Pancreatic Neoplasms, Melanoma, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Cancer Patients | Patients with a cancer diagnosis enrolled on protocol 03-C-0277 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 10 years
Availability of stored specimens and/or data
Availability of stored specimens and/or data to approved research laboratories and investigators
Measured: Approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start30 Jan 2018
- Primary completion27 Aug 2019
- Study completion30 Sep 2019
Why it stopped: Investigator left NIH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancersStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven A Rosenberg, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407040
- Sponsor's protocol ID
- 180043
- Other IDs
- 18-C-0043
- Status last verified
- Nov 2021
- First submitted
- 20 Jan 2018
- Last updated
- 10 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 23290140Vizcardo 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 23290135Parent 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Cancer Antigen-Specific T-cells From Human Induced Pluripotent Stem Cells (iPSC) for Research and Potential Future Therapy
- ClinicalTrials.gov ID
- NCT03407040
- Acronym / sponsor ID
- 180043
- Keywords
- Blood, Tissue, Immunotherapy, Tumor, Somatic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left NIH
- Enrolment
- 98 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Cancer Patients | – | –Patients with a cancer diagnosis enrolled on protocol 03-C-0277 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a cancer diagnosis enrolled on protocol 03-C-0277
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -Healthy donors enrolled on protocol 03-C-0277.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Production of cancer antigen-specific T-cells
Time frame: Approximately 10 years
Reprogram patient specimens into induced pluripotent stem cells (iPSC) and differentiate them into different types of somatic cells
Availability of stored specimens and/or data
Time frame: Approximately 10 years
Availability of stored specimens and/or data to approved research laboratories and investigators
Results and safety
The study was stopped early (reason given: Investigator left NIH). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Background: PubMed 23290140Nishimura 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.
- Background: PubMed 23290135Vizcardo 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.
- Background: PubMed 23684540Parent 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven A Rosenberg, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancers and Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator left NIH). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of cancer antigen-specific T-cells (time frame: Approximately 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03407040, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.