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NCT05316701 · ClinicalTrials.gov registry record · Phase 3
Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
A Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Orca Biosystems.
- Active
- Registry status
- Phase 3
- Development phase
- 187
- Enrollment target
- 19
- Study locations
NCT05316701 is a Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by Orca Biosystems. The registered enrollment target is 187 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (63% higher). The trial reports 19 study locations across 13 states.
The verdict
NCT05316701, a Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by Orca Biosystems.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 187 participants
- Enrollment target
- 19
- 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. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2022-06-21 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
Interested in This 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, categorized as Phase 3. The registered enrollment target is 187 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 (63% higher). The listed sponsor is Orca Biosystems, which has 4 total studies on file at ClinicalTrials.gov.
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.
NCT05316701 reports 19 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, New York.
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.
What interventions are being tested in trial NCT05316701?
The interventions under investigation include: Orca-T (BIOLOGICAL), Standard-of-Care (BIOLOGICAL).
Who is sponsoring clinical trial NCT05316701?
This trial is sponsored by Orca Biosystems, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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