Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (NCT05316701)
A 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 T Cells, or Standard-of-Care Allogeneic Graft
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope — Duarte, California
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (19 Sites)
- City of Hope — Duarte, California
- Ronald Reagan UCLA Medical Center — Los Angeles, California
- UC Davis — Sacramento, California
- Stanford Health Care — Stanford, California
- Colorado Blood Cancer Institute — Denver, Colorado
- University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center — Miami, Florida
- Moffitt Cancer Center — Tampa, Florida
- Winship Cancer Institute - Emory University — Atlanta, Georgia
- University of Chicago — Chicago, Illinois
- Massachusetts General Hospital — Boston, Massachusetts
- University of Michigan Health System - Michigan Medicine — Ann Arbor, Michigan
- Weill Cornell Medicine - New York-Presbyterian Hospital — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Cleveland Clinic — Cleveland, Ohio
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma
- Oregon Health & Sciences University - Knight Cancer Institute — Portland, Oregon
- Vanderbilt University — Nashville, Tennessee
- Sarah Cannon Research Institute — Nashville, Tennessee
- University of Utah — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.