๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-12

Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (NCT04013685)

A Phase Ib 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

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Orca Biosystems, Inc.

๐Ÿฉบ 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.

Who can join: Review the eligibility criteria below.

Location: City of Hope โ€” Duarte, California

Age range: 18 Years to 75 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (21 Sites)

  • City of Hope โ€” Duarte, California
  • Ronald Reagan UCLA Medical Center โ€” Los Angeles, California
  • UC Davis โ€” Sacramento, California
  • Stanford Health Care โ€” Stanford, California
  • Colorado Blood Cancer Institute โ€” Denver, Colorado
  • University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center โ€” Miami, Florida
  • Moffitt Cancer Center โ€” Tampa, Florida
  • Winship Cancer Institute - Emory University โ€” Atlanta, Georgia
  • University of Chicago โ€” Chicago, Illinois
  • The University of Kansas Hospital โ€” Kansas City, Kansas
  • Massachusetts โ€” Boston, Massachusetts
  • University of Michigan Health System - Michigan Medicine โ€” Ann Arbor, Michigan
  • Weill Cornell Medicine - New York-Presbyterian Hospital โ€” New York, New York
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Cleveland Clinic โ€” Cleveland, Ohio
  • OU Health Stephenson Cancer Center โ€” Oklahoma City, Oklahoma
  • Oregon Health & Sciences University - Knight Cancer Institute โ€” Portland, Oregon
  • Sarah Cannon Research Institute โ€” Nashville, Tennessee
  • Vanderbilt University โ€” Nashville, Tennessee
  • University of Texas MD Anderson Cancer Center โ€” Houston, Texas
  • University of Utah - Huntsman Cancer Institute โ€” Salt Lake City, Utah

๐Ÿ“ž 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.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—