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Obecabtagene autoleucel · Aucatzyl

Cell therapy (CAR-T) · Kills target cells, directed at CD19 · developed by Autolus

Approved FDA, Nov 2024
AUTL Developer
4 Registered trials

What is Obecabtagene autoleucel?

Obecabtagene autoleucel is an autologous T cell immunotherapy made from the patient's own T cells genetically modified to express an anti-CD19 chimeric antigen receptor with a 4-1BB co-stimulatory domain. It binds CD19 on target cells, activating CD3-zeta signaling and killing CD19-expressing cells. It is used in relapsed or refractory B-cell precursor acute lymphoblastic leukemia and is studied in progressive multiple sclerosis.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Aucatzyl, AUTO1, Obe-cel
Drug type
Cell therapy (CAR-T)
Targets
CD19 (antigen)
Mechanism
Kills target cells, directed at CD19
Pathways
CD3-zeta signaling, 4-1BB co-stimulation
Therapy area
Neurology, Oncology
Developer
Autolus Inc. (AUTL)
Also in trials of
IQV
FDA status
Approved as Aucatzyl (November 8, 2024), BLA125813 · FDA label

✅ FDA-approved uses

From the indications section of the FDA label (version of Jun 23, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07053059 Phase 2 Acute Lymphocytic Leukemia (ALL) Recruiting AUTL
NCT04404660 Phase 1/2 Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia Active not recruiting AUTL
NCT07139743 Phase 1 Progressive Multiple Sclerosis Recruiting AUTL
NCT06799221 N/A Lymphoblastic Leukemia, Acute, Adult Available AUTL

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Acute Lymphocytic Leukemia (ALL)Progressive Multiple SclerosisRelapsed or Refractory B Cell Acute Lymphoblastic LeukemiaB Cell ALLLymphoblastic Leukemia, Acute, Adult

Other drugs acting on CD19

More from Autolus

Sources

Updated Oct 8, 2026. Something wrong or missing? Report it on the AUTL page.

Follow AUTL, the company behind Obecabtagene autoleucel

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.