OncoMatch/Clinical Trials/NCT05322850
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Is NCT05322850 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Orca-Q for acute myeloid leukemia.
Treatment: Orca-Q — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Myeloid Leukemia
Prior therapy
Cannot have received: myeloablative allogeneic hematopoietic cell transplant
Lab requirements
Blood counts
Marrow blasts < 5% by morphologic examination; Absolute neutrophil count > 1.0 × 10^9/L; Platelet count > 100 × 10^9/L; CRi: All CR criteria except for residual neutropenia (< 1.0 × 10^9/L) or thrombocytopenia (< 100 × 10^9/L)
Kidney function
Serum creatinine within normal range for age and estimated GFR by Schwartz equation >70 ml/min/1.73m2. If serum creatinine is higher than normal, obtain creatinine clearance or nuclear medicine glomerular filtration rate. GFR of ≥ 70 mL/minute/1.73m2 is required.
Liver function
Total bilirubin < 1.5 times upper limit of normal (ULN) (< 3 times if attributed to Gilbert's syndrome) and ALT/AST < 4 times ULN
Cardiac function
Cardiac ejection fraction at rest ≥ 50% by echocardiogram or radionuclide scan (MUGA)
Serum creatinine within normal range for age and estimated GFR by Schwartz equation >70 ml/min/1.73m2... Cardiac ejection fraction at rest ≥ 50% by echocardiogram or radionuclide scan (MUGA)... Total bilirubin < 1.5 times upper limit of normal (ULN) (< 3 times if attributed to Gilbert's syndrome) and ALT/AST < 4 times ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Florida · Gainesville, Florida
- University of Miami · Miami, Florida
- Nicklaus Children's Hospital · Miami, Florida
- Johns Hopkins All Children's Hospital · St. Petersburg, Florida
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