drugset
Drugs / Orca-T
last change Jul 2026 re-read 2 minutes ago

Orca-T

also known as Treg CD34+HSPC · TRGFT-201

Cell therapy

Developed for
myelodysplastic syndrome · acute lymphoblastic leukemia · mixed phenotype acute leukemia · acute myeloid leukemia · acute undifferentiated leukemia · CD4+/CD56+ hematodermic neoplasm · chronic myeloid leukemia · lymphoid leukemia
Investigated by
Orca Biosystems, Inc. · Stanford University · American Society of Hematology · City of Hope Medical Center · Incyte Corporation · National Cancer Institute (NCI)
+1 more · National Marrow Donor Program

Trials 7 · a red edge is where a trial was stopped

today NCT07216443 · Ph 2 NCT06551584 · Ph 1 NCT06195891 · Ph 1 NCT05507827 · Ph 1 NCT05316701 · Ph 3 NCT04013685 · Ph 1
20202021202220232024202520262027202820292030
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT06551584 Dec 2025 → Dec 2026 expected acute lymphoblastic leukemia, mixed phenotype acute leukemia, myelodysplastic syndrome Stanford University Recruiting No outcome recorded
Phase 1 NCT06195891 May 2024 → Mar 2030 expected acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome City of Hope Medical Center Recruiting No outcome recorded
Phase 1 NCT05507827 Aug 2022 → Jun 2025 overdue lymphoid leukemia Stanford University Active not recruiting No outcome recorded
Phase 1 NCT04013685 Nov 2019 → Apr 2025 overdue CD4+/CD56+ hematodermic neoplasm, acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia +1 Orca Biosystems, Inc. Active not recruiting No outcome recorded
Phase 21 trial
Phase 2 NCT07216443 Dec 2025 → Nov 2027 expected mixed phenotype acute leukemia, myelodysplastic syndrome Orca Biosystems, Inc. Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT05316701 Jun 2022 → Jul 2024 overdue acute lymphoblastic leukemia, acute undifferentiated leukemia, mixed phenotype acute leukemia, myelodysplastic syndrome Orca Biosystems, Inc. Active not recruiting No outcome recorded
Phase not stated1 trial
— NCT07346105 — acute lymphoblastic leukemia, mixed phenotype acute leukemia, myelodysplastic syndrome Orca Biosystems, Inc. Temporarily not available No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as Orca-T ClinicalTrials.gov intervention name — accepted as the source's own label NCT07346105 ↗
5

NCT05507827 ↗

NCT07216443 ↗

NCT04013685 ↗

NCT05316701 ↗

NCT06551584 ↗
Known as Treg CD34+HSPC “Treg CD34+HSPC (Orca-T)” NCT05507827 ↗
Known as TRGFT-201 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06195891 ↗
Modality Cell therapy “It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons)” NCT04013685 ↗