Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)

Inclusion Criteria

• •Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative
• •Ability and willingness to adhere to protocol's Schedule of Activities and other requirements
• •Participants must be 12 to 65 years of age inclusive at the time of signing the informed consent.
• •Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding
• •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 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith.
• •Severe, Active SLE defined as:
• •* SLEDAI-2K score of ≥ 8 points AND
• •* Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV)
• •Refractory SLE defined as failure to previous lines of therapy