Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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

NCT05316701 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • BIOLOGICAL Orca-T
  • BIOLOGICAL Standard-of-Care

Study Locations (19)

California

  • City of Hope — Duarte
  • Ronald Reagan UCLA Medical Center — Los Angeles
  • UC Davis — Sacramento
  • Stanford Health Care — Stanford

Florida

  • University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center — Miami
  • Moffitt Cancer Center — Tampa

New York

  • Weill Cornell Medicine - New York-Presbyterian Hospital — New York
  • Memorial Sloan Kettering Cancer Center — New York

Tennessee

  • Vanderbilt University — Nashville
  • Sarah Cannon Research Institute — Nashville

Colorado

  • Colorado Blood Cancer Institute — Denver

Georgia

  • Winship Cancer Institute - Emory University — Atlanta

Illinois

  • University of Chicago — Chicago

Massachusetts

  • Massachusetts General Hospital — Boston

Trial Details

FieldValue
Enrollment Target 187 participants
Start Date 2022-06-21
Est. Completion 2026-07
Phase Phase 3

Sponsor

Orca Biosystems

35 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05316701

The ClinicalTrials.gov registry entry for NCT05316701 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orca Biosystems, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions — of which Orca-T is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05316701 reports 19 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05316701 about?

NCT05316701 is a clinical study titled "Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies". 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...

What is the current status of trial NCT05316701?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 187 participants. The study started on 2022-06-21. Estimated completion is 2026-07.

What conditions does trial NCT05316701 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Leukemia, Mixed Phenotype Acute Leukemia, Acute Lymphoid Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05316701?

The interventions under investigation include: Orca-T (BIOLOGICAL), Standard-of-Care (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05316701?

This trial is sponsored by Orca Biosystems, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05316701 being conducted?

This trial has 19 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial