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: 09 Mar 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 Mar 2026 According to an Orca Bio media release, data from the trial will be presented in oral and poster sessions at the 52nd Annual Meeting of the EBMT from March 22-25 in Madrid.
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.

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