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 (Sep 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
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Myeloid Leukemia
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05322850 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior myeloablative allogeneic hematopoietic cell transplant disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 50 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify