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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07216443
The ClinicalTrials.gov registry entry for NCT07216443 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (72% lower). The listed sponsor is Orca Biosystems, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.
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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.