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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.

Orca-Q

Alexandra Mueller, MS

Beate Greer

Jordan Milner, MD

Priscilla Haakenson

Edward Ziga, MD, MPH

Damaris Rodriguez

Jorge Galvez Silva, MD

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.

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

Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT) Recipients With Hematologic Malignancies (HM)

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

Evaluate secondary graft failure through day +100, defined as neutrophil engraftment followed by subsequent decline in absolute neutrophil counts to \<500 µL, unresponsive to growth factor therapy and in the absence of alternative explanations such as recurrence of the underlying malignant disorder, infections, microangiopathy, medications causing bone marrow suppression or immune-mediated cytopenia.

Evaluate non-relapse mortality, defined as death without evidence of disease recurrence, at 12 months post-transplant

Evaluate non-relapse mortality, defined as death without evidence of disease recurrence, at 24 months post-transplant.

Determine the overall survival at 24 months post-transplant, as defined as the time from the date of transplant to the date of death from any cause or, for surviving patients, to the date of last follow-up.

Determine the relapse rate, as defined as the incidence of disease relapse through 12 months post-transplant. Disease relapse is defined as any of the following: ≥ 5% blasts in the bone marrow or peripheral blood, reappearance of pre-transplant cytogenetic abnormality, new evidence or redevelopment of extramedullary disease. Institution of any therapy to treat relapsed disease, such as withdrawal of immunosuppression or donor lymphocyte infusion (DLI), will be considered evidence of relapse regardless of whether any of these are met.

Determine the relapse rate, as defined as the incidence of disease relapse through 24 months post-transplant. Disease relapse is defined as any of the following: ≥ 5% blasts in the bone marrow or peripheral blood, reappearance of pre-transplant cytogenetic abnormality, new evidence or redevelopment of extramedullary disease. Institution of any therapy to treat relapsed disease, such as withdrawal of immunosuppression or donor lymphocyte infusion (DLI), will be considered evidence of relapse regardless of whether any of these are met.

Determine the rate of acute GVHD at 6 months post-transplant

Determine the rate of chronic GVHD through 24 months post-transplant.

Determine the rate of serious infections by 12 months post-transplant. A serious infection is defined as any new viral, bacterial, fungal or parasitic infection Common Terminology Criteria for Adverse Events v5.0 grade 2 or higher.

Describe treatment-emergent adverse events through 24 months post-transplant.

Evaluate the GVHD-free, relapse-free survival at 12 months post-transplant. GVHD-free, relapse-free survival is defined as freedom from grade III or IV acute GVHD, moderate or severe chronic GVHD, or disease progression or relapse.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)	NCT05322850	Acute Myeloid L... Acute Lymphoid ... Mixed Phenotype... Acute Undiffere... Chronic Myeloid... Chronic Myeloid... Chronic Myeloid...	Orca-Q	- 50 Years	University of Florida
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)	NCT05322850	Acute Myeloid L... Acute Lymphoid ... Mixed Phenotype... Acute Undiffere... Chronic Myeloid... Chronic Myeloid... Chronic Myeloid...	Orca-Q	- 50 Years	University of Florida

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