Drugs / BSB-1001
last change Feb 2025 re-read 3 minutes ago

BSB-1001

Cell therapy

Developed for
acute myeloid leukemia · adult acute lymphoblastic leukemia · myelodysplastic syndrome
Investigated by
BlueSphere Bio, Inc

Trials 1

20252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT06704152 Feb 2025 → Feb 2029 expected acute myeloid leukemia, adult acute lymphoblastic leukemia, myelodysplastic syndrome BlueSphere Bio, Inc Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2024-06-03 BlueSphere Bio, Inc Regulatory BlueSphere Bio Announces IND Clearance of its First in Human Candidate and New Cell Therapy Portfolio for High-Risk Leukemia Patients bluespherebio.com ↗
the Food and Drug Administration (FDA) has cleared BlueSphere’s Investigational New Drug application (IND) for a Phase 1/2a trial (TCX-101) of its first-in-human (BSB-1001) product candidate
2022-11-10 BlueSphere Bio, Inc Results BlueSphere Bio Presents Data Demonstrating the Potential of Lead Product Candidate at 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting bluespherebio.com ↗
Data supports BSB-1001 as a potential treatment to improve outcomes for patients with acute myeloid leukemia (AML) receiving a hematopoietic stem cell transplantation (HSCT)

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as BSB-1001 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06704152 ↗
Modality Cell therapy “new type of cellular therapy” NCT06704152 ↗
Route Intravenous “single intravenous (IV) infusion” NCT06704152 ↗