Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05322850
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acute Lymphoid Leukemia
  • Acute Myeloid Leukemia
  • Acute Undifferentiated Leukemia
  • Chronic Myeloid Leukemia - Accelerated Phase
  • Chronic Myeloid Leukemia in Lymphoid Blast Crisis (Diagnosis)
  • Chronic Myeloid Leukemia in Myeloid Blast Crisis
  • Mixed Phenotype Acute Leukemia

Eligibility Criteria

Sex
ALL
Age
N/A - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Orca-Q — BIOLOGICAL
    All transplant recipients enrolled on this study in both the phase I and phase II portions will receive Orca-Q (Orca-Q Prime and Orca-Q Supplement) intravenously following myeloablative conditioning.

Study Details

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.

Key Dates

First listed
Apr 12, 2022
Start date
Aug 16, 2022
Status verified
Aug 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Orca-Q

Primary Outcome Measure

Primary graft failure [ Time Frame: 28 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608
Beate Greer
[email protected]
352-294-8744
Jordan Milner, MD (PRINCIPAL_INVESTIGATOR)
Nicklaus Children's HospitalMiamiFlorida33155-
University of MiamiMiamiFlorida33136-
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-

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