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Active, not recruiting Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT04013685

Public ClinicalTrials.gov record NCT04013685. 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 Oct 22, 2026, 9:23 AM EDT

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

Official title

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

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.

Study identification

NCT ID
NCT04013685
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Orca Biosystems, Inc.
Industry
Enrollment
155 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 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
Nov 21, 2019 (Actual)
Primary completion
Apr 30, 2025 (Actual)
Completion
Apr 2027 (Estimated)
Last update posted
Aug 14, 2026

2019 – 2027

United States locations

U.S. sites
21
U.S. states
15
U.S. cities
19
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 —
The University of Kansas Hospital Kansas City Kansas 66160 —
Massachusetts 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 —
Sarah Cannon Research Institute Nashville Tennessee 37203 —
Vanderbilt University Nashville Tennessee 37232 —
University of Texas MD Anderson Cancer Center Houston Texas 77054 —
University of Utah - Huntsman Cancer Institute 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 NCT04013685, 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 Aug 14, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04013685 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →