This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.
Women or men ≥ 18 years at screening [Spain only] or patients 12 to 65 years of age (inclusive) at the time of signing the informed consent [UK only]
Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus
Positive for at least one of the following autoantibodies: antinuclear antibodies (ANA) at a titer of ≥ 1:80, or anti-dsDNA (≥ 30 IU/mL) or anti-Smith (> upper limit of normal [ULN]), anti-histone or anti-chromatin (> ULN)
Severe, refractory SLE
Medications
Within 2 months of leukapheresis: use of anti-CD20 therapy
Prior treatment with anti-CD19 therapy (including bispecifics), adoptive T cell therapy or any prior gene therapy product (e.g., CAR T cell therapy)
Immunization with a live or attenuated vaccine within 2 months of leukapheresis
Single group
Obecabtagene autoleucel (obe-cel)
Biological/VaccineFollowing lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a single dose of obe-cel
Dose-limiting toxicities
Percentage of patients receiving obe-cel who experience dose-limiting toxicities (DLTs)
Adverse events
Adverse event (AE) type, frequency, severity, and relationship with obe-cel and lymphodepletion of AEs
Remission rate according to Definition of Remission in SLE (DORIS)
Remission rate as specified by Definition of Remission in SLE (DORIS)
Response over time according to Definition of Remission in SLE (DORIS)
Response over time as specified by Definition of Remission in SLE (DORIS)
Time to response according to Definition of Remission in SLE (DORIS)
Time to response as specified by Definition of Remission in SLE (DORIS)
Change over time in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Change compared to baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score. The total score is the sum of all marked SLE-related descriptors. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
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