A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Trea… (NCT07389499) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
China30 participantsStarted 2026-05-30
Plain-language summary
This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase. In the dose-escalation phase, approximately 9-18 adult participants with immune-mediated kidney diseases are planned to be enrolled and treated with GT719 universal cell injection. The objectives of this phase are to evaluate the safety and tolerability of the product, determine the recommended dose (RD) for subsequent studies, conduct a preliminary assessment of its clinical efficacy, and investigate the pharmacokinetic and pharmacodynamic characteristics. Upon completion of the dose-escalation phase, after evaluation by investigators and collaborators, an appropriate dose will be selected for the dose-expansion phase. An additional 12 participants will be enrolled to fully assess the safety and efficacy of the product.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Prior treatment with glucocorticoids, budesonide enteric-coated capsules, immunosuppressants (including mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, Tripterygium wilfordii, leflunomide, azathioprine), or biological agents (including but not limited to anti-CD20 monoclonal antibodies, telitacicept, daratumumab) for a cumulative duration of at least 3 months, with persistent 24-hour urinary protein ≥ 0.75 g or UPCR ≥ 0.75 g/g.
✓. The predicted probability of a 50% decline in eGFR or end-stage renal disease (ESRD) within 5 years calculated by the international IgAN prediction tool is ≥ 20%.
✓. A ≥ 20% decline in eGFR within 3 months.
✓. Renal biopsy performed within 6 months indicating Oxford classification C2 lesion.
✓. Patients who are intolerant to conventional treatment and for whom the investigator determines that the benefits outweigh the risks, with adequate informed consent obtained, may be considered for inclusion.
✓. Previous diagnosis of steroid-resistant nephrotic syndrome (SRNS): 24-hour urinary protein \> 3 g or UPCR ≥ 3.5 g/g, serum albumin \< 30 g/L, failure to achieve complete remission after 4 weeks of standard-dose glucocorticoid treatment.
✓. Previous diagnosis of steroid-dependent nephrotic syndrome (SDNS): Remission achievable with glucocorticoid treatment, but relapse within 2 weeks of glucocorticoid tapering or discontinuation, or two consecutive relapses during glucocorticoid tapering.
What they're measuring
1
Safety and Tolerability: Evaluate the incidence, correlation with the investigational product, severity, and other relevant aspects of adverse events (AEs) and serious adverse events (SAEs) occurring in participants during the trial
Timeframe: 24 Months
2
Changes in vital signs before and after treatment
Timeframe: 1 Month
3
Changes in clinical symptoms before and after treatment
Timeframe: 1 Month
4
Changes in laboratory tests before and after treatment
Timeframe: 1 Month
5
Changes in electrocardiograms before and after treatment
✓. Previous diagnosis of frequently relapsing nephrotic syndrome (FRNS): ≥ 3 relapses within 1 year or ≥ 2 relapses within 6 months after achieving complete remission with glucocorticoid treatment.
✕. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN;
✕. Left ventricular ejection fraction (LVEF) ≥ 50% diagnosed by echocardiography.
✕. Pulmonary function: Defined as dyspnea ≤ CTCAE Grade 1 and oxygen saturation (SpO₂) ≥ 92% at rest while breathing room air (measured by pulse oximetry).