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2018-01-30
2019-08-27
2019-09-30
98
NCT03407040
National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
OBSERVATIONAL
Generation of Cancer Antigen-Specific T-cells From Human Induced Pluripotent Stem Cells (iPSC) for Research and Potential FutureTherapy
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. ...
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-01-20 | N/A | 2021-11-09 |
2018-01-20 | N/A | 2021-11-10 |
2018-01-23 | N/A | 2021-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 1/Cancer Patients Patients with a cancer diagnosis enrolled on protocol 03-C-0277 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
15 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
