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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Universal STAR-T Cell
Biological/VaccineThere are three dose levels of STAR-T cells injection(1.5 E6 STAR-T cells/kg, 3.0 E6 STAR-T cells/kg and 4.5 E6 STAR-T cells/kg) .
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Universal STAR-T CellExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Type, severity, and frequency of adverse events (AEs)
Characterization of treatment-emergent adverse events (TEAEs) graded by NCI-CTCAE v6.0, including laboratory abnormalities, vital sign changes, and infusion-related reactions.
Time frame
AEs will be observed until 24 weeks after STAR-T cells injection and extended to 104 weeks.2
Incidence of Dose-Limiting Toxicities (DLTs).
To assess the safety and tolerability of STAR-T cells and determine the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D). DLTs are defined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Time frame
Within 28 days after START-T cells infusion.3
Remission rates of IgAN at the week 12 and week 24
Remission include complete remission (CR) or partial remission (PR). (1) Complete remission (CR) is defined as 24-hour urine protein \< 0.5 g, or a 24-hour urine protein-to-creatinine ratio (UPCR) \< 0.5 g/g, accompanied by stable renal function which is defined as a decline in estimated glomerular filtration rate (eGFR) of ≤ 15% from baseline. (2) Partial remission (PR) is defined as 24-hour urine protein or 24-hour UPCR not meeting the CR criteria, but demonstrating a reduction of ≥ 50% from baseline.
Time frame
From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively4
Remission rates of PMN at the week 12 and week 24
Remission include complete remission (CR) or partial remission (PR). (1) Complete remission (CR) is defined as 24-hour urine protein \< 0.5 g, or a 24-hour urine protein-to-creatinine ratio (UPCR) \< 0.5 g/g, accompanied by stable serum creatinine (defined as a fluctuation of ≤ 15% from baseline), and a serum albumin (ALB) level \> 3.5 g/dL (or 35 g/L). (2) Partial remission (PR) is defined as 24-hour urine protein maintained within the range of 0.5-3.5 g, or 24-hour UPCR maintained within the range of 0.5-3.5 g/g, accompanied by a reduction of ≥ 50% from baseline
Time frame
From enrollment to the end of treatment at 12 weeks and 24 weeks, respectivelySecondary outcomes
1
Changes in 24-hour UPCR from baseline in IgAN and PMN participants
24-hour urine sample will be collected and UPCR will be measured.
Time frame
From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively2
Changes in 24-hour urinary protein excretion from baseline in IgAN and PMN participants
24-hour urine sample will be collected and urinary protein excretion will be measured.
Time frame
From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively3
Changes in kidney function from baseline in IgAN and PMN participants
eGFR will be measured to evaluate kidney fucntion
Time frame
From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively4
Changes in serum biomarkers from baseline in IgAN participants
Biomarkers include serum albumin, Gd-IgA1, C3, C4 and Immunoglobulins.
Time frame
From enrollment to the end of treatment at 12 weeks and 24 weeks, respectivelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangdong Provincial People's Hospital
Lead sponsor
China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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