Collection of Samples From Patients With MDS

PersImmune

Status: Unknown

Conditions: Myelodysplastic Syndromes(MDS)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03072498

161345

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients must meet the following initial inclusion criteria:

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

Patient 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