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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: Active Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Orca Biosystems.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The incidence of primary graft failure
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2019-11-21 |
| Est. Completion | 2027-04 |
| Phase | Phase 1 |
What the registry record for NCT04013685 still lists
NCT04013685 is an interventional study that assigns participants to a tested intervention. The registered 255 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 (122% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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Where NCT04013685's enrollment target sits among peer trials
255 34th of 306 higher than 272 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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