Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis (NCT07053800) | Clinical Trial Compass
RecruitingPhase 2
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
United States35 participantsStarted 2026-01-16
Plain-language 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.
Who can participate
Age range12 Years – 65 Years
SexALL
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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 washo…
What they're measuring
1
Proportion of participants who achieve complete renal response (CRR) at 6 months post-obe-cel infusion without rescue medications, among all participants who received obe-cel infusion