Tests obe-cel cell therapy in lupus with active kidney inflammation
Tests obe-cel, a single infusion, in people with severe lupus and kidney inflammation.
Plain-language title generated from the registry record
Registry title: Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Key facts
- Where
- Houston, New York, San Antonio, and Syracuse, United StatesSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 65 years old?
Source: NCT07053800, who can take part
Where in United States
- Texas Children's HospitalHouston, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Texas Transplant InstituteSan Antonio, United StatesTaking people
- State University of New York Upstate Medical Center (SUNY)Syracuse, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Autolus Limited
- Trial code
- NCT07053800EU 2024-519941-32-00
- Record updated
- 30 October 2026
- Original description
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).Read full original descriptionShow less
A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).
Inclusion: 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: 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.