Phase 1, Open‑Label Study of LBL‑051 in Adults with Refractory B‑cell–Mediated Autoimmune Diseases

The trial enrolled both female and male patients, including individuals classified as vulnerable, with the sponsor not providing the total number of participants. Participants were selected as patients with B-cell–mediated autoimmune diseases. The age range of enrolled subjects corresponded to the study’s predefined categories coded as 3 and 4. No additional lifestyle or health status details were supplied.

The study is a Phase 1 interventional trial evaluating LBL-051 in adults with refractory B-cell–mediated autoimmune diseases. After an initial screening visit to confirm eligibility, participants receive a single dose of study medication and are monitored at scheduled follow‑up visits (e.g., weeks 2, 4, 8, and monthly thereafter) to assess safety, pharmacokinetics, and preliminary efficacy. The trial is planned to recruit from July 2026 and complete by June 2028, with each participant remaining in the study for approximately 12 months, concluding with an end‑of‑study visit that includes final assessments and study drug discontinuation. Early termination may occur if a participant experiences a serious adverse event, withdraws consent, fails to meet protocol compliance, or exhibits disease progression that necessitates alternative therapy.

No experimental medication, comparator, or standard‑of‑care details are provided in the source data.