ClinicaliQ Trial Snapshot
- Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis — Recruiting • Phase II • Rheumatology • NCT07053800.
- What is being tested: Obe-cel, a B-cell targeted therapy designed to eliminate pathogenic B cells in patients with severe, refractory SLE and active lupus nephritis who have failed conventional treatments.
- Patient eligibility overview: Adults with biopsy-confirmed lupus nephritis that has proven resistant to standard disease-modifying therapies, representing a treatment-refractory population with significant unmet clinical need.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.