Universal STAR-T Cell Injection in Autoimmune Kidney Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangdong Provincial People's Hospital
About this trial
This is an investigator initiated, single-arm, open-label, dose-escalation study to explore the preliminary efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection which is a CD19 and BCMA bispecific CAR-T cells in patients with autoimmune kidney diseases. Approximately 10-24 adult participants diagnosed as IgA nephropathy and primary membranous nephropathy will be enrolled. Three dose levels (1.5 E6 STAR-T cells/kg, 3.0 E6 STAR-T cells/kg and 4.5 E6 STAR-T cells/kg) will be established in this study, and the universal STAR-T cell will be administered as a single intravenous infusion. A recommended dose will be selected for subsequent dose-expansion studies to evaluate the safety and efficacy of universal STAR-T cell injection in participants with autoimmune kidney diseases based on the safety, PK results, and preliminary efficacy data. This study includes the screening period (D-28 to D-6), pre-clearance treatment and observation period (D-5 to D-1), cell infusion and main study endpoint observation period (D0 to W12 after infusion), and extended follow-up period (W12 to W104).
Eligibility criteria
Qualifiers
Age 18-65 years (inclusive), gender (no gender restriction);
Previous diagnosis of IgA Nephropathy (IgAN) or Primary Membranous Nephropathy (PMN)：
Treatment-refractory IgAN: Previously received RAAS inhibitors or SGLT2 inhibitors or endothelin receptor antagonists (ERA) or mineralocorticoid receptor antagonists (MRA) for at least 12 weeks, and combined with/or sequentially added at least one immunosuppressant or biologic agent for ≥3 months, with 24-hour urinary protein ≥1.0 g or 24-hour urine protein/creatinine ratio (UPCR) ≥0.8 g/g;
eGFR decreased by ≥50% within the past 3 months, and acute kidney injury (AKI) is excluded;
Disqualifiers
Secondary IgAN, secondary membranous nephropathy;
Use of immunosuppressive agents with therapeutic effect on the disease within five half-lives prior to cell infusion, or biologics within 4 weeks;
History of severe drug allergy or allergic constitution;
Uncontrolled or requiring treatment fungal, bacterial, viral, or other infections;
Trial design
Treatments tested in this trial
- Universal STAR-T Cell
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Guangdong Provincial People's Hospital
Lead sponsor
China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborator
Source ClinicalTrials.gov