Evaluation of Anti-CD19 CAR NK Cell KN5501 Therapy for Adults With Relapsed or Refractory Immune Nephropathy Assessing Safety and Effectiveness in Patients Aged 18 to 70

What this Trial Is About

Researchers are evaluating the safety and effectiveness of anti-CD19 CAR NK cell injection KN5501 in patients with immune nephropathy who have relapsed or refractory disease. This early-phase, single-arm, open-label pilot study plans to enroll 36 adults aged 18 to 70 years. The primary goals are to assess dose-limiting toxicities and treatment-emergent adverse events, with secondary goals including overall response and disease control rates. Participants will receive conditioning chemotherapy with Fludarabine and Cyclophosphamide on days -5, -4, and -3 before multiple infusions of anti-CD19 CAR NK cells KN5501 following a 3 3 dose-escalation design. This approach aims to explore safe dosing levels and monitor patient responses throughout the treatment period. During the study, participants will be closely monitored for safety up to 48 weeks after infusion. Researchers will assess response rates, disease control, and B cell levels at 1, 3, 6, and 12 months post-infusion. Participants will undergo laboratory tests, clinical evaluations, and follow-up visits to evaluate treatment effects and manage any side effects over the course of the study.

An Exploratory Clinical Study of Anti-CD19 CAR NK Cell (KN5501) in the Treatment of Relapsed/Refractory Immune Nephropathy