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AUTO CAR T cell therapy

Phase 2

Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy | Monoclonal antibody | Oncology |Autolus Therapeutics plc|Last Updated: Aug 7, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03628612Long-term Follow-up of Patients Treated With Genetically Modified Autologous T CellsPHASE2 ENROLLING BY_INVITATION 500 — — Aug 2, 2018Dec 1, 2043Aug 7, 20258 United States, United Kingdom
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Study Endpoints
Primary Endpoints
Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy
For up to 15 years

Monitoring of all SAEs / AESIs, including any new malignancy or new diagnosis of neurologic disorders, or other hematologic disorder, related to AUTO CAR T cell therapy. Monitoring of all adverse events of special interest related to AUTO CAR T cell therapy infusion.

Secondary Endpoints
Overall Survival following first AUTO CAR T cell therapy infusion.
Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
Duration of supportive care
Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
Duration of response
Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
AUTO CAR T cell therapyEXPERIMENTALPatients who received previous treatment with AUTO CAR T Cell Therapy
Interventions
NameTypeDescription
AUTO CAR T cell therapyBIOLOGICALNo study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion.
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Eligibility Criteria
Age Range1 Year — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Patients must have received an AUTO CAR T cell therapy on a clinical treatment study. 2. Patients must have provided informed consent for long-term follow-up study prior to participation. 3. Patients must be able to comply with the study requirements. Exclusion Criteria: 1....

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT03628612primaryCompletionDate: changed
LOWMay 24, 2026NCT03628612studyFirstPostDate: changed