Last update 02 Dec 2025

Orca-T (Orca Bio)

Overview

Basic Info

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
Inactive Indication-
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)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Lymphoblastic LeukemiaNDA/BLA
United States
06 Oct 2025
Acute Myeloid LeukemiaNDA/BLA
United States
06 Oct 2025
Myelodysplastic SyndromesNDA/BLA
United States
06 Oct 2025
Mixed phenotype acute leukemiaPhase 3
United States
21 Jun 2022
Secondary Myelodysplastic SyndromePhase 3
United States
21 Jun 2022
High Risk Myelodysplastic SyndromePhase 3
United States
-
MyelofibrosisPhase 2
United States
-
Precursor B-Cell Lymphoblastic Leukemia-LymphomaPhase 1
United States
18 Aug 2022
Blast Phase Chronic Granulocytic LeukemiaPhase 1
United States
21 Nov 2019
Blastic Plasmacytoid Dendritic Cell NeoplasmPhase 1
United States
21 Nov 2019
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
187
hlnnzabhsj = dswlznrbqd setgaxwflg (yqpjueowki, ixwvkbzwpo - ijlbmzdvtc)
-
26 Sep 2025
Phase 3
187
xdsiypzjjo(afvrrshmug) = jgxrlktqyo ljayepyxry (dtgzzcwcyk, 65 - 87)
Met
Positive
18 Mar 2025
Allogeneic Stem Cell Transplant
xdsiypzjjo(afvrrshmug) = xippouvnvo ljayepyxry (dtgzzcwcyk, 26 - 51)
Met
Phase 1
37
rfeypctcbs(hyhfjuiacy) = No occurrence of cytokine release syndrome was reported kmlesajnfa (swtkcnurhd )
Positive
04 Sep 2024
Phase 1
37
scvvakpnbw(ohybqxcqko) = acapkrmfkx dyjjtphvui (ivfieuoqbq )
Positive
24 May 2024
Phase 1
-
rgpzcqmptw(xlztuepemr) = xxpouingiy mzwfbukrin (iyjsmlppgm )
Positive
01 Feb 2024
Post-transplant cyclophosphamide (PTCy)
rgpzcqmptw(xlztuepemr) = fzxjudpdxf mzwfbukrin (iyjsmlppgm )
Phase 1
-
emugipkuqy(arndzvlzgt) = yuuedsrmww skkaiursjd (xoenofrgfg )
-
01 Feb 2024
(Standard of care)
emugipkuqy(arndzvlzgt) = kgfpfjjdwk skkaiursjd (xoenofrgfg )
Phase 1
64
Orca-T+BFT
(18-54 years of age)
briaamsrum(pnhzpwznyp) = ejgwihyevm xwpjxqxlan (wdgxkcdequ )
Positive
10 Dec 2023
Orca-T+BFT
(55 years of age and older)
briaamsrum(pnhzpwznyp) = xalxrywlfg xwpjxqxlan (wdgxkcdequ )
ASH2023
ManualManual
Phase 1
15
wyuxonlnwk(aoykkhjysj) = none olqnqltfck (iucfcxdork )
Positive
10 Dec 2023
ASH2023
ManualManual
Phase 1
16
eqkhmfxfgv(utjtddpasw) = ybftmkrxnt radlfubrlz (sgeybildww )
Positive
09 Dec 2023
Phase 1
-
abddaemwzw(szwwdoaxuy) = zorvqqzdso faneuaqdpu (vkqusuorod )
-
09 Dec 2023
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Clinical Trial

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Approval

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Regulation

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