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NCT07216443 · ClinicalTrials.gov registry record · Phase 2
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Orca Biosystems.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 5
- Study locations
NCT07216443: Recruiting Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Orca Biosystems.
NCT07216443 is a Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute that is actively recruiting participants, run by Orca Biosystems. The registered enrollment target is 80 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (72% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07216443, a Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, is actively recruiting participants, sponsored by Orca Biosystems.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is 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).
Primary Outcome
GRFS is defined as the time from the date of transplantation to the date of death from any cause, relapse, the first onset of grade 3 or 4 acute GVHD (graded per MAGIC criteria), or the first onset of moderate or severe chronic GVHD (graded per NIH consensus criteria), whichever is earliest.
Conditions Studied
Interventions
- BIOLOGICAL Orca-T
Study Locations (5)
California
- UCLA Department of Medicine - Los Angeles
Florida
- Moffitt Cancer Center - Tampa
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack
Oregon
- Oregon Health and Science University - Portland
Tennessee
- Vanderbilt University, Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-12-09 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT07216443 shows while recruiting
NCT07216443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (72% lower).
The record links to 3 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which Orca-T is the first listed.
NCT07216443 lists 5 locations in 5 states (California, Florida, New Jersey).
Frequently Asked Questions
What is clinical trial NCT07216443 about?
NCT07216443 is a clinical study titled "Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome". This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is an allogeneic stem cell and T-cell immunotherapy biologic manufa...
What is the current status of trial NCT07216443?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2025-12-09. Estimated completion is 2028-12.
What conditions does trial NCT07216443 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Mixed Phenotype Acute Leukemia.
What interventions are being tested in trial NCT07216443?
The interventions under investigation include: Orca-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT07216443?
This trial is sponsored by Orca Biosystems, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07216443 being conducted?
This trial has 5 study locations across California, Florida, New Jersey, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07216443's enrollment target sits among peer trials
80 66th of 173 higher than 105 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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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