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A Phase 1 Non-Randomized/Phase 2 Randomized Study of ProTmune (ex vivo Programmed Mobilized Peripheral Blood Cells) for Allogeneic Hematopoietic Cell Transplantation in Adult Patients with Hematologic Malignancies

Clinical Trial Details

The purpose of this study is to gain new knowledge about an investigational treatment called ProTmune (also known as ex vivo programmed mobilized peripheral blood cells). Investigational means that ProTmune is still being studied and that study doctors are trying to determine whether ProTmune causes side effects, and if it is effective for treating different types of blood cancers. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved this treatment.

ProTmune is prepared from blood cells that are collected from a matched unrelated donor. After the collection, these cells are modified using special chemicals, also called reagents. The modification of the blood cells is the investigational part of the study.

This study consists of two consecutive phases, Phase 1 and Phase 2. The purpose of the Phase 1 portion of the research study was to evaluate the safety of the ProTmune treatment on mobilized peripheral blood to be used in transplantation. The purpose of the Phase 2 portion of the research study is to evaluate if ProTmune can prevent or reduce complications that frequently happen during transplantation, which include graft versus host disease (GvHD). Safety will also be evaluated in this phase of the study. For a period of time, after you receive your transplant and when your immune (self-defense) system recovers, you may be at a higher risk of infection.

Key Eligibility: 

Inclusion Criteria

  • Open to men and women above the age of 18 who have been diagnosed with Hematologic Malignancies. 
  • Patients must have a hematologic malignancy for which allogeneic hematopoietic peripheral blood cell transplantation is deemed clinically appropriate   

Exclusion Criteria

  • Phase 1 only: known bone marrow fibrosis; Phase 2 only: Bone marrow fibrosis grade 3 (severe) or greater;
  • Positive serology for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) at any time prior to enrollment;
  • Currently uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms despite therapy);
  • Prior autologous or allogeneic HCT

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Ashlee N. Torres, RN
(212) 746-7117
ant9105@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1605017254

ClinicalTrials.gov:

NCT02743351

Sponsor:

PT-001

Status

Open to Enrollment

Sponsor