NCT07053800 Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
| NCT ID | NCT07053800 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Autolus Limited |
| Condition | Lupus Nephritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-01-16 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 35 participants in total. It began in 2026-01-16 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial aims to find out if obe-cel gets rid of harmful B cells that contribute to systemic lupus erythematosus (SLE)/lupus nephritis (LN) when available treatments have not worked (refractory). The trial includes only 1 group of patients (single arm), including adolescent and adult patients aged 12 to 65 years. The objective is to look for benefits of obe-cel in making signs of LN completely disappear (remission) at 6 months after obe-cel treatment in patients with severe, active LN. The trial will also look for other benefits of obe-cel for up to 24 months after treatment, including the percentage of patients who respond to obe-cel treatment, SLE/LN activity, time to and length of remission, and quality of life. The trial will also assess how long obe-cel stays in the body and the safety of obe-cel.
Eligibility Criteria
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: * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 8 points AND * Severe active LN based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V (V only in combination with class III or IV) * Refractory SLE defined as failure to early lines of therapy and to Calcineurin inhibitors AND B cell-targeting agents Exclusion Criteria: * Any medications prohibited by the protocol. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07053800 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 65 Years, studying Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07053800 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07053800 currently recruiting?
Yes, NCT07053800 is actively recruiting participants. Contact the research team at clinicaltrials@autolus.com for enrollment information.
Where is the NCT07053800 trial being conducted?
This trial is being conducted at Gilbert, United States, Duarte, United States, Stanford, United States, Tampa, United States and 11 additional locations.
Who is sponsoring the NCT07053800 clinical trial?
NCT07053800 is sponsored by Autolus Limited. The trial plans to enroll 35 participants.
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