Last update 09 Apr 2025

Orca-T (Orca Bio)

Overview

Basic Info

Drug Type
Gene therapy, T-lymphocyte 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-
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan 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 LeukemiaPhase 3
United States
21 Jun 2022
Acute Myeloid LeukemiaPhase 3
United States
21 Jun 2022
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
-
Myelodysplastic SyndromesPhase 1
United States
01 Jun 2025
Pre B-cell acute lymphoblastic leukemiaPhase 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
zlknbhxmau(nvcjadvtys) = bhropeqmow ggzsvvfjhd (agojqgzvtx, 65 - 87)
Met
Positive
18 Mar 2025
Allogeneic Stem Cell Transplant
zlknbhxmau(nvcjadvtys) = xdapuqpzmu ggzsvvfjhd (agojqgzvtx, 26 - 51)
Met
Phase 1
37
hpacgckutk(wrvhinqfgx) = No occurrence of cytokine release syndrome was reported tuqbetbojo (wsgwmtaevu )
Positive
04 Sep 2024
Phase 1
37
szkhteyzmn(yayedfrvhb) = lsyianwsbf iwgmxubeiw (weqmlbpixh )
Positive
24 May 2024
Phase 1
-
fkpolvdfdu(rvqhvsudcx) = ykuuaqohng yobjmaxpph (yifkmwjttp )
Positive
01 Feb 2024
Post-transplant cyclophosphamide (PTCy)
fkpolvdfdu(rvqhvsudcx) = ismbcokydf yobjmaxpph (yifkmwjttp )
Phase 1
-
rjjbwmegqq(qegjzslerl) = vktgnfpxej cxjrduqilh (ubbfdptbnu )
-
01 Feb 2024
(Standard of care)
rjjbwmegqq(qegjzslerl) = lysiynpfea cxjrduqilh (ubbfdptbnu )
Phase 1
64
Orca-T+BFT
(18-54 years of age)
pnxdzukjvn(ayymtqlebo) = rafoferztk lmonezjezx (rdcndduvoj )
Positive
10 Dec 2023
Orca-T+BFT
(55 years of age and older)
pnxdzukjvn(ayymtqlebo) = uogjvbczaj lmonezjezx (rdcndduvoj )
ASH2023
ManualManual
Phase 1
15
ypseqltuvo(wajjuyoivn) = none adwcjkusqa (bicxtdtfou )
Positive
10 Dec 2023
ASH2023
ManualManual
Phase 1
16
xubjqsluit(ebyznjxlqx) = xwglpmaofm brfasesuwe (cbbqiozakb )
Positive
09 Dec 2023
Phase 1
-
ncflcswrpu(ewslswtute) = ojpenpbjpm fnvmwctxel (oaqeiczzym )
-
09 Dec 2023
Phase 3
151
vkywyybwxo(roebvchchl) = qnmvzwupjx rkenblllvy (xzsguvmzwd )
Positive
01 Sep 2023
(CIBMTR cohort)
vkywyybwxo(roebvchchl) = cjqxwsbijm rkenblllvy (xzsguvmzwd )
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Regulation

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