Collection of Samples From Patients With MDS

NCT ID: NCT03072498

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-06

Study Completion Date

2021-03-05

Brief Summary

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The purpose of this study is to collect information and bone marrow, blood, saliva, cheek cells and skin to be used in the laboratory to assist the sponsor in identifying a new way of treating MDS.

Detailed Description

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Goals of the study:

The purpose of this study is to collect the blood and marrow samples, and non-involved fibroblasts, that are required to identify the unique, personalized array of mutation-driven neoantigens that are expressed by the subject's MDS cells and to assess the feasibility of immunizing and expanding one or more of the patient's T cells ex vivo for investigation of their use as adoptive cellular immunotherapy.

Conditions

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Myelodysplastic Syndromes(MDS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis or suspected diagnosis of MDS or CCUS
* Age 18 or older

Exclusion Criteria

* Currently receiving or within 3 months has received hypomethylating agent(s), lenalidomide, cytotoxic agents, or within the previous 4 weeks corticosteroids \> 5 mg prednisone daily or any other immunosuppressants
* Previous allogenic transplant
* Inability to provide consent
* Prisoners
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

PersImmune, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafael Bejar, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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University of California, Irvine

Irvine, California, United States

Site Status RECRUITING

University of California San Diego

La Jolla, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rafael Bejar, MD

Role: CONTACT

858-822-5485

Tiffany Tanaka, MD

Role: CONTACT

858-534-8575

Facility Contacts

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Chao Family Comprehensive Cancer Center

Role: primary

877-827-8839

Jessica Limson

Role: backup

7145096233

Colin McCarthy

Role: primary

858-534-8127

Kimberly Aguilar

Role: backup

858-534-5201

Other Identifiers

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161345

Identifier Type: -

Identifier Source: org_study_id

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