Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: January 16, 2026
End Date: October 01, 2029
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
Exclusion Criteria:
- Prior treatment at any time with anti-CD19 therapy
- More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible
- Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant
- History of primary antiphospholipid antibody syndrome
- Active or uncontrolled fungal, bacterial, or viral infection
- History of malignant neoplasms unless disease free for at least 24 months
- History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant
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Conditions:
- Lupus Nephritis
- Lupus Erythematosus, Systemic