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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 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.

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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.

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

FieldValue
Enrollment Target 40 participants
Start Date 2022-08-16
Est. Completion 2027-09
Phase Phase 1

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT05322850

The ClinicalTrials.gov registry entry for NCT05322850 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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