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FELIX: AUTO1 in Relapsed or Refractory B Cell ALL
NCT04404660Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Jun 2020
- Primary completion
- Jun 2029
- Countries
- 3
- Sponsor
- Autolus Therapeutics plc
- Modality
- Gene Editing, Gene Silencing, CAR-T Cells
- Conditions
- B cell acute lymphoblastic leukemia (B-ALL)
01
Overview
Phase 2, open-label, single-arm trial of obecabtagene autoleucel in B cell acute lymphoblastic leukemia (B-ALL), sponsored by Autolus Therapeutics plc. Primary endpoints: Frequency and severity of adverse events and serious adverse events at 24 months and Overall Response Rate at 24 months. Started Jun 2020; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
AUTO1
Single arm receiving pre-conditioning followed by AUTO1 (Obecabtagene autoleucel) split dose.
03
Who it enrols
Adults with relapsed/refractory B-cell ALL, ECOG 0-1, CD19 positive. Excludes isolated extramedullary disease, Burkitt's, active CNS disease, active infections, HIV/HBV/HCV, and prior CD19 therapy other than blinatumomab.
04
Endpoints
Primary
Frequency and severity of adverse events and serious adverse events
Overall Response Rate
Secondary
Proportion of patients achieving MRD-negative CR
Complete remission rate
Duration of remission
Progression-free survival
Overall survival
Incidence of severe hypogammaglobulinemia
Duration of severe hypogammaglobulinemia
Detection of CAR T cells measured following AUTO1 infusion
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