eClinical Technology and Industy News

Orca Bio Announces the Precision-T Phase 3 Study is Open and Enrolling Patients at Transplant Centers Across the U.S.

– The pivotal Precision-T Study is evaluating the safety and efficacy of Orca Bio’s investigational Orca-T compared to standard of care allogeneic hematopoietic stem cell transplant –

– Precision-T is expected to enroll approximately 174 patients across more than 20 clinical trial sites –

Excerpt from the Press Release:

MENLO PARK, Calif.–(BUSINESS WIRE)–Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced Precision-T, its pivotal Phase 3 study, is open, enrolling and treating patients at clinical trial sites including Stanford Health Care, City of Hope, Winship Cancer Institute of Emory University, Sarah Cannon Research Institute, Ronald Reagan UCLA Medical Center and Oregon Health & Science University. Precision-T is expected to enroll approximately 174 patients at more than 20 transplant centers across the U.S.

Precision-T (NCT05316701) is a randomized, open-label multi-center study that is evaluating the safety and efficacy of Orca Bio’s lead investigational high-precision cell therapy, Orca-T, compared to standard of care allogeneic hematopoietic stem cell transplant (standard allo-HSCT). Orca Bio received guidance from the Food and Drug Administration on the design of Precision-T, which will evaluate Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS).

“By precision engineering the donor graft, we aim to create a cell therapy that retains the benefits of transplant without serious complications like graft versus host disease and disease relapse,” said Robert Negrin, M.D., professor of medicine at the Stanford School of Medicine. “This has been demonstrated by the recent results of the Phase 1b/2 single-arm trials with Orca-T, and we are pleased to be evaluating this novel cell therapy in a randomized Phase 3 clinical trial.”

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