HealthyNCT03114566
Collection and Generation of Antigen-specific T-lymphocyte Cell Lines From Primary, Third-party, Related, and Unrelated Donors
An observational study of Healthy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to obtain lymphocyte collections from normal healthy volunteer donors in order to create Good Manufacturing Practice grade banks of virus-specific and tumor-reactive T-cells of defined HLA type and restricting HLA allele readily available for therapeutic use. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Leukapheresis
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2017to 2 Feb 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Transplant donors and healthy HLA typed volunteers
Who may be able to join
- Donors must satisfy standards including those set forth by FACT (Foundation for the Accreditation of Cellular Therapy) and the criteria specified in FDA 21 Code of Federal Regulations (CFR) 1271. Specifically, screening for risk factors for communicable disease as well as infectious disease screening by serologic and PCR testing as outlined below. Including testing for IV, Hepatitis B, Hepatitis C, HTLV I and II, CMV, EBV, and toxoplasmosis, westnile virus, syphilis, varicella zoster, and Chagas disease.
- Donors must be typed for HLA-A, B, C, DR and DQ at high resolution.
- Donors accrued at MSKCC must have a hemoglobin value > 10g/dl
- Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood
- Donors must weight >/= 25 kg
Who cannot join
- HTLV/HIV (+) or Hepatitis B or C positive donors
- Donors who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to obtain lymphocyte collections from normal healthy volunteer donors in order to create Good Manufacturing Practice grade banks of virus-specific and tumor-reactive T-cells of defined HLA type and restricting HLA allele readily available for therapeutic use.
- Conditions
- Healthy
- Being tested
- Leukapheresis
- Keywords
- transplant donor, HLA typed, 17-211
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeukapheresisOther
Blood is removed together with an anticoagulant from a vein and separated into white cell rich and red cell rich fractions by centrifugation. The white cells are then saved to generate immune cells and the red cells are reinfused back through the donor's vein.
| Study group | Role | What they receive |
|---|---|---|
| Consenting healthy donor | Transplant and healthy HLA typed donors Receives: Other: Leukapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of T-cells
Blood and/or white cell donations will be used for the generation of the T-cells to be used for adoptive immunotherapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start5 Apr 2017
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Prockop, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114566
- Sponsor's protocol ID
- 17-211
- Status last verified
- Feb 2021
- First submitted
- 11 Apr 2017
- Last updated
- 5 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection and Generation of Antigen-specific T-lymphocyte Cell Lines From Primary, Third-party, Related, and Unrelated Donors
- ClinicalTrials.gov ID
- NCT03114566
- Acronym / sponsor ID
- 17-211
- Conditions
- Healthy
- Keywords
- transplant donor, HLA typed, 17-211
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 14 Apr 2017 (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.
The purpose of this study is to obtain lymphocyte collections from normal healthy volunteer donors in order to create Good Manufacturing Practice grade banks of virus-specific and tumor-reactive T-cells of defined HLA type and restricting HLA allele readily available for therapeutic use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consenting healthy donor | – | Other: LeukapheresisTransplant and healthy HLA typed donors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Transplant donors and healthy HLA typed volunteers
Key inclusion criteria (5 listed)
- Donors must satisfy standards including those set forth by FACT (Foundation for the Accreditation of Cellular Therapy) and the criteria specified in FDA 21 Code of Federal Regulations (CFR) 1271. Specifically, screening for risk factors for communicable disease as well as infectious disease screening by serologic and PCR testing as outlined below. Including testing for IV, Hepatitis B, Hepatitis C, HTLV I and II, CMV, EBV, and toxoplasmosis, westnile virus, syphilis, varicella zoster, and Chagas disease.
- Donors must be typed for HLA-A, B, C, DR and DQ at high resolution.
- Donors accrued at MSKCC must have a hemoglobin value > 10g/dl
- Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood
- Donors must weight >/= 25 kg
Key exclusion criteria (2 listed)
- HTLV/HIV (+) or Hepatitis B or C positive donors
- Donors who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeukapheresisBlood is removed together with an anticoagulant from a vein and separated into white cell rich and red cell rich fractions by centrifugation. The white cells are then saved to generate immune cells and the red cells are reinfused back through the donor's vein. | Other | Consenting healthy donor |
Primary outcome
Generation of T-cells
Time frame: 1 year
Blood and/or white cell donations will be used for the generation of the T-cells to be used for adoptive immunotherapy.
Results and safety
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Susan Prockop, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Healthy, run by Memorial Sloan Kettering Cancer Center 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 5 inclusion and 2 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 5 Feb 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: Lack of accrual). 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?
Generation of T-cells (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2021.