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A Phase Ib /Randomized Phase III Trial of Patients with Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation with Either Orca-T, a T-cell-Depleted Graft with Additional Infusion of Conventional T cells and Regulatory

Clinical Trial Details

This clinical trial is for men and women who have advanced hematologic malignancies (blood cancers) that may be treated with a blood stem cell transplant.
   
The purpose of this research study is to find out if an experimental therapy, Orca-T, can be safely given as a blood stem cell transplant to patients with blood cancers and pre-cancerous conditions and if Ora-T results in less graft vs host disease (GVHD) than standard blood stem cell transplants.
   
Orca-T is considered experimental because it has not yet been approved by the United States Food and Drug Administration (FDA).

Orca-T is engineered in the lab that leverages donor T cells to control immune responses.

Participants in this study will be randomized to receive one of two treatments. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group. The first group will receive Orca-T and the second group will receive the standard-of-care unmanipulated allograft derived from the peripheral blood of a matched donor.
   
Total study participation will last for approximately 2 years or until the study doctor feels it is in the participant’s best interest to discontinue the study treatment.

Key Eligibility: 
  1. Men and women who have advanced blood cancer
  2. Planning to undergo an allogeneic hematopoietic stem cell transplantation
  3. Matched to a related or unrelated donor      

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

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2003021655

ClinicalTrials.gov:

NCT05316701

Sponsor:

Precision-T

Status

Open to Enrollment

Age Group

Adult

Sponsor