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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: Active Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Orca Biosystems.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Event-free rate estimated at 12 months for cGFS per EAC, which is defined as the time from date of allogeneic hematopoietic cell transplantation (alloHCT) (ie, day 0) to date of death from any cause or first onset of moderate or severe chronic graft-versus-host disease (cGVHD) (graded per NIH consensus criteria), whichever was earliest, within 2 years after day 0. cGVHD was assessed and graded by EAC blinded to treatment assignment. Each participant in the study is followed for up to 730 days a
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 |
What the registry record for NCT05316701 still lists
NCT05316701 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (63% higher).
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 lists 19 locations in 13 states (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.
Learn More About Clinical Trials
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Where NCT05316701's enrollment target sits among peer trials
187 47th of 306 higher than 260 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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