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AUTO1

Phase 1

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia | Monoclonal antibody | Oncology |Autolus Therapeutics plc|Last Updated: Apr 8, 2026

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
UNCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment183
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06173518A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)PHASE1 RECRUITING 30Nov 16, 2023Nov 1, 2027Mar 2, 20268 United States, Spain +1
NCT04404660A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)PHASE1 ACTIVE NOT_RECRUITING 153Jun 3, 2020Jun 30, 2029Apr 8, 202634 United States, Spain +1
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Study Endpoints
Primary Endpoints
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Up to 24 months
Incidence and duration of severe hypogammaglobulinemia
Up to 24 months
Proportion of pediatric participants with r/r B ALL at screening who achieve complete remission (CR) within 3 months of obe-cel infusion per Independent Response Review Committee (IRRC) assessment
3 months
Phase 1b - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion
Up to 24 months
Phase 2 - Cohort IIA: ORR defined as proportion of patients achieving CR or CRi as assessed by an IRRC.
Up to 24 months
Secondary Endpoints
CR per IRRC assessment at any time in B ALL
Up to 24 months
Overall remission rate (ORR) (CR + complete remission with incomplete recovery of counts [CRi]) per IRRC assessment at any time in B ALL
Up to 24 months
Minimal residual disease (MRD)-negative ORR per IRRC assessment at any time in B ALL
Up to 24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AUTO1EXPERIMENTAL -
Interventions
NameTypeDescription
AUTO1BIOLOGICALFollowing lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells
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Eligibility Criteria
Age Range0 Years — 18 Years
SexALL
Healthy VolunteersNo
Study Sites8

INCLUSION CRITERIA: * \< 18 years old at screening * ≥ 6 kg body weight at screening Pediatric patients with r/r B ALL r/r CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) ...

Countries:United StatesSpainUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06173518primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT04404660Phase: PHASE1/PHASE2 → PHASE1
LOWMay 24, 2026NCT06173518studyFirstPostDate: changed
LOWMay 24, 2026NCT04404660studyFirstPostDate: changed