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.
1. The participant or their legal representative voluntarily signs a written informed consent form, and is willing and able to comply with the procedures of this study.
2. Aged 18 to 75 years (inclusive) at the time of signing the informed consent, regardless of gender.
3. Positive expression of CD19 on B cells in peripheral blood is confirmed by flow cytometry.
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.
Drug-induced or secondary AAV/AAGN.
Alveolar hemorrhage requiring invasive mechanical ventilation support at screening.
Monoclonal deposition caused by secondary nephropathy (e.g., those diagnosed with multiple myeloma or severe systemic lymphoplasmacytic disease requiring immediate oncological treatment).
6. History of severe hypersensitivity reaction or allergy.
Single group
CD19-targeted iNKT Cell Injection
Biological/VaccineComposed of CD19-targeted iNKT cells
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
Based on the current version of the Common Terminology Criteria for Adverse Events (CTCAE) developed by the National Cancer Institute (NCI) of the United States, a systematic assessment of the safety and tolerability of the study subjects was conducted throughout the entire trial period.
Changes in vital signs before and after treatment
Dynamic monitoring of changes in vital signs before and after treatment, including heart rate, body temperature, blood pressure, etc.
Changes in clinical symptoms before and after treatment
A comparative analysis of the dynamic changes in clinical symptoms before and after treatment, including skin changes, pulmonary conditions, etc., is planned to be conducted.
Changes in laboratory tests before and after treatment
A comparative analysis of the dynamic changes in laboratory test indicators, including blood routine, blood biochemistry, relevant antibodies, etc., is planned to be conducted.
All Participants: Time to Maximum Expansion of Infused Cells (Tmax)
The time point at which the concentration of infused cells in peripheral blood reaches the peak level following product infusion, measured by flow cytometry.
All Participants: Peak Expansion Level of Infused Cells (Cmax)
The maximum copy number or cell count of infused cells in peripheral blood after infusion, measured by flow cytometry.
All Participants: Area Under the Curve of Infused Cells (AUC)
The area under the concentration-time curve of infused cells in peripheral blood from the time of infusion to the evaluation endpoint, reflecting the total exposure of cells in vivo.
All Participants: Duration of Observable Concentration (Tlast)
The time period during which the concentration of a drug, cell (e.g., CAR-T cell), or biomarker in the body can be stably detected continuously after reaching or exceeding the Lower Limit of Quantitation (LLOQ) of the detection method.
Peripheral Blood Lymphocyte Subsets
Lymphocyte populations in peripheral blood with distinct surface markers and functional characteristics.
Exploration of T Cells by B Lymphocyte Subsets
Taking B lymphocyte subsets as the research tool/entry point, this study explores their interaction with T cells, as well as the functional impacts and regulatory mechanisms involved.
Changes in NK cells
Detect the dynamic changes in the quantity, proportion, activity, and phenotypic characteristics of natural killer (NK) cells.
HLA Typing/Antibody Changes
The dynamic changes in the genotyping characteristics of Human Leukocyte Antigen (HLA) and the anti-HLA antibody profile in the body.
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Grit Biotechnology
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
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