Trial Profile

A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 25 Feb 2026

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At a glance

Drugs Orca-Q (Primary) ; Busulfan; Fludarabine; Thiotepa
Indications Acute biphenotypic leukaemia; Acute myeloid leukaemia; Myelodysplastic syndromes; Myelofibrosis; Precursor cell lymphoblastic leukaemia-lymphoma
Focus Adverse reactions; Therapeutic Use
Sponsors Orca Bio

02 Sep 2025 Protocol was amended to include three new arms (Arm, D, E, F), it has been changed from 3 to 6.
02 Sep 2025 Planned number of patients changed from 186 to 300.
02 Sep 2025 Planned End Date changed from 1 Apr 2028 to 1 Dec 2027.

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