obecabtagene autoleucel

Cell therapyapprovedOrphan Drug FDA

Approved

Nov 8, 2024

Clinical trial activity

5 trials · 4 clinical orgs · 0 marketing orgs

Phase 1
2
Phase 2
2
Phase 3
0
Phase 4
0

Earliest trial started Feb 2, 2024 (NCT06333483)

Timeline

2010s

  1. Nov 4, 2019

    Orphan Drug Designation

2020s

  1. Jan 1, 2024

    Earliest Phase 1 Sponsor(trial)

  2. Nov 8, 2024

    Earliest FDA Approval

  3. Jan 1, 2025

    Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedNov 8, 2024

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Black box warning

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07053800Phase 2Sep 30, 2025Autolus Limited, PPD
NCT07053059Phase 2Aug 26, 2025University of Texas at Houston
NCT07139743Phase 1Aug 4, 2025Autolus Limited
NCT06333483Phase 1Feb 2, 2024Autolus Limited
NCT06799221N/AAutolus Limited, IQVIA
Showing 5 of 5 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Autolus LimitedFor profit4432024
IQVIAFor profit101
PPDFor profit1012025
University of Texas at HoustonAcademic/Hospital1112025
4 organizations
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