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Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT05316701

Public ClinicalTrials.gov record NCT05316701. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 1, 2026, 8:04 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05316701
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Orca Biosystems, Inc.
Industry
Enrollment
187 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 21, 2022 (Actual)
Primary completion
Jul 15, 2024 (Actual)
Completion
Jul 2026 (Estimated)
Last update posted
Mar 4, 2026

2022 – 2026

United States locations

U.S. sites
19
U.S. states
13
U.S. cities
17
Facility City State ZIP Site status
City of Hope Duarte California 91010 —
Ronald Reagan UCLA Medical Center Los Angeles California 90095 —
UC Davis Sacramento California 95817 —
Stanford Health Care Stanford California 94305 —
Colorado Blood Cancer Institute Denver Colorado 80218 —
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center Miami Florida 33136 —
Moffitt Cancer Center Tampa Florida 33612 —
Winship Cancer Institute - Emory University Atlanta Georgia 30322 —
University of Chicago Chicago Illinois 60637 —
Massachusetts General Hospital Boston Massachusetts 02114 —
University of Michigan Health System - Michigan Medicine Ann Arbor Michigan 48109 —
Weill Cornell Medicine - New York-Presbyterian Hospital New York New York 10021 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
Cleveland Clinic Cleveland Ohio 44195 —
OU Health Stephenson Cancer Center Oklahoma City Oklahoma 73104 —
Oregon Health & Sciences University - Knight Cancer Institute Portland Oregon 97239 —
Vanderbilt University Nashville Tennessee 37232 —
Sarah Cannon Research Institute Nashville Tennessee 37239 —
University of Utah Salt Lake City Utah 84112 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05316701, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 4, 2026 · Synced Nov 1, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05316701 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →