Trial Profile
A Randomized Phase III Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Either Orca-T, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells, or Standard-of-Care Allogeneic Graft
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 03 Jul 2026
Price :
$35
*
At a glance
- Drugs Allogeneic regulatory T cell immunotherapy with HSPC and T cells vldq Orca Bio (Primary) ; Methotrexate; Tacrolimus
- Indications Acute biphenotypic leukaemia; Acute myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
- Focus Registrational; Therapeutic Use
- Acronyms Precision-T
- Sponsors Orca Bio
Most Recent Events
- 30 Jun 2026 According to Food and Drug Administration media release, based on the data from the trial the U.S FDA has approved TREGZI (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), clinically known as Orca-T, in the treatment of adults with hematological malignancies.
- 01 Apr 2026 According to an Orca Bio media release, company announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of its Biologics License Application (BLA) for Orca-T for the treatment of patients with hematologic malignancies. The new Prescription Drug User Fee Act (PDUFA) target action date is July 6, 2026.
- 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.