{"entity":{"id":"nct05316701","kind":"trial","name":"Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies","aka":["Precision-T"],"tldr":"A phase 3 trial of Orca-T in acute myeloid leukaemia and myelodysplastic syndromes / neoplasms, run by Orca Biosystems, Inc., active and no longer recruiting.","summary":"Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies is a phase 3 interventional study registered as NCT05316701 by Orca Biosystems, Inc., with 187 participants enrolled, started 2022-06-21 and due to reach its primary completion in 2024-07-15. Interventions recorded: Orca-T and Standard-of-Care. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05316701","url":"https://clinicaltrials.gov/study/NCT05316701"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","mds"],"sections":[],"technologies":["allogeneic-cell-therapy"],"targets":[],"drugs":["tregzi"],"companies":["orca-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05316701","phase":"3","setting":"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","sponsor":"Orca Biosystems, Inc.","started":"2022-06-21","startedType":"actual","yearReported":2025,"enrolled":187,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC)","primary":true,"unit":"%","arms":[{"name":"Orca-T","n":93,"value":78,"note":"95% CI 65.0 to 86.6; Figures from the ClinicalTrials.gov results section (first posted 2025-09-26), not from a publication"},{"name":"Standard of Care","n":94,"value":38.4,"note":"95% CI 26.2 to 50.5"}],"hr":0.26,"ci":[0.14,0.47],"p":"<0.00001","source":"https://clinicaltrials.gov/study/NCT05316701?tab=results"},{"endpoint":"Event-free at 12 Months for Overall Survival (OS)","unit":"%","arms":[{"name":"Orca-T","n":93,"value":93.9,"note":"95% CI 85.8 to 97.4; Figures from the ClinicalTrials.gov results section (first posted 2025-09-26), not from a publication"},{"name":"Standard of Care","n":94,"value":83.1,"note":"95% CI 72.9 to 89.8"}],"hr":0.49,"ci":[0.2,1.22],"p":"0.11823","source":"https://clinicaltrials.gov/study/NCT05316701?tab=results"}]},"route":"/trials/nct05316701/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"mds","kind":"cancer","name":"Myelodysplastic syndromes / neoplasms (MDS)","route":"/cancers/mds/"}],"technology":[{"id":"allogeneic-cell-therapy","kind":"technology","name":"Allogeneic (off-the-shelf) cell therapy","route":"/technologies/allogeneic-cell-therapy/"}],"drug":[{"id":"tregzi","kind":"drug","name":"Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq","route":"/drugs/tregzi/"}],"company":[{"id":"orca-bio","kind":"company","name":"Orca Bio","route":"/companies/orca-bio/"}]}}