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NCT04013685 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Orca Biosystems.

Active
Registry status
Phase 1
Development phase
255
Enrollment target
20
Study locations

NCT04013685 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is active but no longer recruiting, run by Orca Biosystems. The registered enrollment target is 255 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (122% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04013685, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Orca Biosystems.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
255 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndromes Acute Leukemia Chronic Myeloid Leukemia Acute Lymphoid Leukemia Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Interventions

  • BIOLOGICAL Orca-T

Study Locations (20)

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

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

Colorado

  • Colorado Blood Cancer Institute - Denver

Georgia

  • Winship Cancer Institute - Emory University - Atlanta

Illinois

  • University of Chicago - Chicago

Kansas

  • The University of Kansas Hospital - Kansas City

Trial Details

FieldValue
Enrollment Target 255 participants
Start Date 2019-11-21
Est. Completion 2027-04
Phase Phase 1

Sponsor

Orca Biosystems

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04013685

The ClinicalTrials.gov registry entry for NCT04013685 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 255 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (122% higher). The listed sponsor is Orca Biosystems, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Orca-T is the first listed.

NCT04013685 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT04013685 about?

NCT04013685 is a clinical study titled "Precision-T: A 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 NCT04013685?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 255 participants. The study started on 2019-11-21. Estimated completion is 2027-04.

What conditions does trial NCT04013685 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Leukemia, Chronic Myeloid Leukemia, Acute Lymphoid Leukemia.

What interventions are being tested in trial NCT04013685?

The interventions under investigation include: Orca-T (BIOLOGICAL).

Who is sponsoring clinical trial NCT04013685?

This trial is sponsored by Orca Biosystems, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04013685 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.