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NCT05322850 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
A Phase 1 study of Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT05322850: Recruiting Phase 1 study of Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia, sponsored by University of Florida.
NCT05322850 is a Phase 1 study of Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia that is actively recruiting participants, run by University of Florida. The registered enrollment target is 40 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05322850, a Phase 1 study of Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a first in children prospective study of allogeneic hematopoietic cell transplant using a centrally manufactured engineered donor graft (Orca-Q). The study will assess safety and efficacy of Orca-Q in pediatric patients with hematologic malignancies.
Primary Outcome
Evaluate primary graft failure through day +28, defined as being alive without recovery of neutrophils (achieving an absolute neutrophil count \>500/µL for 3 consecutive days) by day +28
Conditions Studied
Interventions
- BIOLOGICAL Orca-Q
Study Locations (4)
Florida
- University of Florida - Gainesville
- University of Miami - Miami
- Nicklaus Children's Hospital - Miami
- Johns Hopkins All Children's Hospital - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-08-16 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
What NCT05322850 shows while recruiting
NCT05322850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower).
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Orca-Q is the first listed.
NCT05322850 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05322850 about?
NCT05322850 is a clinical study titled "Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)". This is a first in children prospective study of allogeneic hematopoietic cell transplant using a centrally manufactured engineered donor graft (Orca-Q). The study will assess safety and efficacy of Orca-Q in pediatric patients with hematologic malignancies.
What is the current status of trial NCT05322850?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-08-16. Estimated completion is 2027-09.
What conditions does trial NCT05322850 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Mixed Phenotype Acute Leukemia, Acute Undifferentiated Leukemia, Acute Lymphoid Leukemia, Chronic Myeloid Leukemia - Accelerated Phase.
What interventions are being tested in trial NCT05322850?
The interventions under investigation include: Orca-Q (BIOLOGICAL).
Who is sponsoring clinical trial NCT05322850?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05322850 being conducted?
This trial has 4 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05322850's enrollment target sits among peer trials
40 170th of 306 higher than 128 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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