Engineered Donor Grafts (Orca-T) for Blood Cancers
Trial Summary
What is the purpose of this trial?
This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.
Eligibility Criteria
This trial is for adults with certain blood cancers like acute leukemia or myelodysplastic syndrome who need a stem cell transplant. They must be relatively healthy, with good liver, kidney, heart and lung function, not have other active cancers or serious infections, and can't be pregnant or breastfeeding. Participants should match an 8/8 HLA donor and cannot have had a previous transplant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an allogeneic hematopoietic cell transplant with the Orca-T product
Follow-up
Participants are monitored for safety and effectiveness after treatment, including incidence of aGVHD and graft failure
Long-term follow-up
Participants are monitored for long-term outcomes such as overall survival and chronic GvHD
Treatment Details
Interventions
- Orca-T
Orca-T is already approved in United States for the following indications:
- Acute Lymphoblastic Leukemia (ALL)
- Acute Myeloid Leukemia (AML)
- Myelodysplastic Syndrome (MDS)
- Myelofibrosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Orca Biosystems, Inc.
Lead Sponsor