Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
Running, not enrolling · Phase 3
Conditions studied: Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Undifferentiated Leukemia, Myelodysplastic Syndrome, Acute Leukemia, Therapy-Related Myelodysplastic Syndrome
In brief
This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685.
Key facts
- Study ID
- NCT05316701
- Run by
- Orca Biosystems, Inc.
- People needed
- 187
- Starts
- 2022-06-21
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
- UC Davis — Sacramento, California, United States
- Stanford Health Care — Stanford, California, United States
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Winship Cancer Institute - Emory University — Atlanta, Georgia, United States
- University of Chicago — Chicago, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University of Michigan Health System - Michigan Medicine — Ann Arbor, Michigan, United States
- Weill Cornell Medicine - New York-Presbyterian Hospital — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
- Oregon Health & Sciences University - Knight Cancer Institute — Portland, Oregon, United States
- Vanderbilt University — Nashville, Tennessee, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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