Phase 1 Study of Orca-Q for Blood Cancers
This study is testing a new treatment called OrcaGraft (Orca-Q) for people with certain blood cancers like acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). OrcaGraft is an engineered donor allograft, which means it's a specially prepared transplant from a donor. The main goals are to see how safe OrcaGraft is and how well people tolerate it, especially looking for serious side effects in the first 28 days. The study also wants to see if the transplant works as expected. You could be eligible if you are between 12 and 78 years old, depending on your specific cancer and donor match. The study plans to enroll up to 300 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 300 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 28 days after receiving Orca-Q/OrcaGraft.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
At a glance
Conditions
Where it's being run
12 sites across 10 statesStudy leadership
- James S McClellan, MD, PhD · STUDY_DIRECTOR · Orca Biosystems, Inc.
Who to contact
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What this trial measures
- Dose Limiting Toxicities through Day +28 (dose escalation)28 Days after administration of Orca-Q/OrcaGraft
Safety and tolerability of Orca-Q (formerly OrcaGraft) in adults undergoing myeloablative allogeneic hematopoietic cell transplantation (MA-alloHCT) will be evaluated by identification of the following dose limiting toxicities: Grade ≥ 3 infusion-related reaction or cytokine release syndrome, Grade ≥ 3 acute GVHD, Any Grade ≥ 3 treatment-related non-hematologic event not clearly related to the underlying malignancy, intercurrent infection, the HCT conditioning regimen, or other pre-existing medical condition
- Primary Graft failure through Day +28 (dose expansion)28 Days after administration of Orca-Q/OrcaGraft
Primary graft failure in the dose expansion phase, defined as being alive without recovery of neutrophils during the evaluation period