Collection and Generation of Antigen-specific T-lymphocyt... | NCT03114566

Studies
Collection and Generation of Antigen-specific T-lymphocyte Cell Lines From Primary, Third-party, Related, and Unrelated Donors

NCT03114566

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Terminated

Last Update Posted

Feb 5, 2021Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Healthy

Interventions

Leukapheresis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of accrual

Expanded Access Info

Start Date

Apr 5, 2017Actual

Primary Completion Date

Feb 2, 2021Actual

Completion Date

Feb 2, 2021Actual

First Submitted Date

Apr 11, 2017

First Submission Date that Met QC Criteria

Apr 13, 2017

First Posted Date

Apr 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2021

Last Update Posted Date

Feb 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Consenting healthy donor		Transplant and healthy HLA typed donors	Other: Leukapheresis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Leukapheresis	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

HTLV/HIV (+) or Hepatitis B or C positive donors
Donors who are pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Transplant donors and healthy HLA typed volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Prockop, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Cancer Center		New York	New York	10065	United States

Label	URL
Memorial Sloan Kettering Cancer Center	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007937	Leukapheresis

Ancestor Terms

ID	Term
D016238	Cytapheresis
D001691	Biological Therapy
D013812	Therapeutics
D001781	Blood Component Removal

Browse Leaves

Not provided

Browse Branches

Not provided