Drug Type Tregs cell therapy |
Synonyms Orca T (Orca Bio), Orca-T (Orca Bio), Treg CD34+HSPC (Orca Bio) + [2] |
Target- |
Action- |
Mechanism Immunologic cytotoxicity, T lymphocyte replacements |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationPriority Review (United States), Orphan Drug (United States), Regenerative Medicine Advanced Therapy (United States) |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Acute Lymphoblastic Leukemia | NDA/BLA | United States | 06 Oct 2025 | |
| Acute Myeloid Leukemia | NDA/BLA | United States | 06 Oct 2025 | |
| Myelodysplastic Syndromes | NDA/BLA | United States | 06 Oct 2025 | |
| Mixed phenotype acute leukemia | Phase 3 | United States | 21 Jun 2022 | |
| Secondary Myelodysplastic Syndrome | Phase 3 | United States | 21 Jun 2022 | |
| High Risk Myelodysplastic Syndrome | Phase 3 | United States | - | |
| Myelofibrosis | Phase 2 | United States | - | |
| Precursor B-Cell Lymphoblastic Leukemia-Lymphoma | Phase 1 | United States | 18 Aug 2022 | |
| Blast Phase Chronic Granulocytic Leukemia | Phase 1 | United States | 21 Nov 2019 | |
| Blastic Plasmacytoid Dendritic Cell Neoplasm | Phase 1 | United States | 21 Nov 2019 |
Phase 3 | 187 | hlnnzabhsj = dswlznrbqd setgaxwflg (yqpjueowki, ixwvkbzwpo - ijlbmzdvtc) View more | - | 26 Sep 2025 | |||
Phase 3 | 187 | xdsiypzjjo(afvrrshmug) = jgxrlktqyo ljayepyxry (dtgzzcwcyk, 65 - 87) Met View more | Positive | 18 Mar 2025 | |||
Allogeneic Stem Cell Transplant | xdsiypzjjo(afvrrshmug) = xippouvnvo ljayepyxry (dtgzzcwcyk, 26 - 51) Met View more | ||||||
Phase 1 | 37 | rfeypctcbs(hyhfjuiacy) = No occurrence of cytokine release syndrome was reported kmlesajnfa (swtkcnurhd ) View more | Positive | 04 Sep 2024 | |||
Phase 1 | Acute Myeloid Leukemia First line | 37 | scvvakpnbw(ohybqxcqko) = acapkrmfkx dyjjtphvui (ivfieuoqbq ) View more | Positive | 24 May 2024 | ||
Phase 1 | - | rgpzcqmptw(xlztuepemr) = xxpouingiy mzwfbukrin (iyjsmlppgm ) View more | Positive | 01 Feb 2024 | |||
Post-transplant cyclophosphamide (PTCy) | rgpzcqmptw(xlztuepemr) = fzxjudpdxf mzwfbukrin (iyjsmlppgm ) View more | ||||||
Phase 1 | - | emugipkuqy(arndzvlzgt) = yuuedsrmww skkaiursjd (xoenofrgfg ) View more | - | 01 Feb 2024 | |||
(Standard of care) | emugipkuqy(arndzvlzgt) = kgfpfjjdwk skkaiursjd (xoenofrgfg ) View more | ||||||
PipelineReview Manual | Phase 1 | 64 | Orca-T+BFT (18-54 years of age) | briaamsrum(pnhzpwznyp) = ejgwihyevm xwpjxqxlan (wdgxkcdequ ) View more | Positive | 10 Dec 2023 | |
Orca-T+BFT (55 years of age and older) | briaamsrum(pnhzpwznyp) = xalxrywlfg xwpjxqxlan (wdgxkcdequ ) View more | ||||||
ASH2023 Manual | Phase 1 | 15 | wyuxonlnwk(aoykkhjysj) = none olqnqltfck (iucfcxdork ) | Positive | 10 Dec 2023 | ||
ASH2023 Manual | Phase 1 | 16 | eqkhmfxfgv(utjtddpasw) = ybftmkrxnt radlfubrlz (sgeybildww ) View more | Positive | 09 Dec 2023 | ||
Phase 1 | - | abddaemwzw(szwwdoaxuy) = zorvqqzdso faneuaqdpu (vkqusuorod ) View more | - | 09 Dec 2023 |





