A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases

NCT07389499 | Not Yet Recruiting Early Phase 1

• 1 other identifier: GRIT-CD-CHN-719-004-055
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ANCA-associated Vasculitis (AAV)/ANCA-associated Glomerulonephritis (AAGN); IgA Nephropathy (IgAN); Membranous Nephropathy; Refractory Podocytopathy; Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits

Outcome Measures

Primary Outcomes (5)

• 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.

  24 Months

• 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.

  1 Month

• 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.

  1 Month

• 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.

  1 Month

• Changes in electrocardiograms before and after treatment

  A comparative analysis of the dynamic changes in electrocardiograms is planned to be conducted.

  1 Month

Secondary Outcomes (17)

• All Participants: Time to Maximum Expansion of Infused Cells (Tmax)

  24 Months

• All Participants: Peak Expansion Level of Infused Cells (Cmax)

  24 Months

• All Participants: Area Under the Curve of Infused Cells (AUC)

  24 Months

• All Participants: Duration of Observable Concentration (Tlast)

  24 Months

• All Participants: CAR-T-associated Serum Cytokines

  2 Months

Other Outcomes (7)

• Peripheral Blood Lymphocyte Subsets

  24 Months

• Exploration of T Cells by B Lymphocyte Subsets

  24 Months

• Changes in NK cells

  24 Months

Study Arms (1)

GT719 Injection treatment group

EXPERIMENTAL

GT719 Injection

Biological: CD19-targeted iNKT Cell Injection

Interventions

CD19-targeted iNKT Cell Injection BIOLOGICAL

Composed of CD19-targeted iNKT cells

GT719 Injection treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Aged 18 to 75 years (inclusive) at the time of signing the informed consent, regardless of gender.
• \. Positive expression of CD19 on B cells in peripheral blood is confirmed by flow cytometry.
• \. Participants with IgA nephropathy (IgAN) at high risk of progression:
• ① A definite pathological diagnosis of IgAN confirmed by renal biopsy (renal biopsy must be performed within 2 years prior to screening or during the screening period).
• Meet at least one of the following requirements:
• 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.
• \. Participants with ANCA-associated vasculitis (AAV)/ANCA-associated glomerulonephritis (AAGN) must meet the following criteria:
• ① Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the 2022 ACR/EULAR classification criteria for ANCA-associated vasculitis.
• ② Positive anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody detected during screening or in previous tests.
• ③ AAGN: Availability of a renal biopsy pathological report within 2 years; if eGFR \< 30 mL/min/1.73 m², a renal biopsy pathological report obtained during the screening period is required. Presence of active lesions according to the 2010 Berden classification criteria for AAGN.
• ④ Renal-uninvolved AAV: Birmingham Vasculitis Activity Score (BVAS) version 3.0 ≥ 3 points, indicating active vasculitis.

You may not qualify if:

• \. Participants with IgA nephropathy (IgAN) at high risk of progression:
• a. Secondary IgAN (e.g., associated with active hepatitis B/hepatitis C infection, HIV, etc.).
• \. Participants with ANCA-associated vasculitis (AAV)/ANCA-associated glomerulonephritis (AAGN):
• Drug-induced or secondary AAV/AAGN.
• Alveolar hemorrhage requiring invasive mechanical ventilation support at screening.
• \. Participants with membranous nephropathy (MN):
• a. Secondary membranous nephropathy.
• \. Participants with refractory podocytopathy:
• a. Hereditary podocytopathy and secondary focal segmental glomerulosclerosis (FSGS).
• \. Participants with proliferative glomerulonephritis with monoclonal immunoglobulin deposition (PGNMID):
• Monoclonal deposition caused by secondary nephropathy (e.g., those diagnosed with multiple myeloma or severe systemic lymphoplasmacytic disease requiring immediate oncological treatment).
• For all participants:
• \. History of severe hypersensitivity reaction or allergy.
• \. Contraindication or hypersensitivity to fludarabine, cyclophosphamide, or any component of the investigational product.
• \. Currently receiving renal replacement therapy or expected to require renal replacement therapy during the study period.

Sponsors & Collaborators

• Grit Biotechnology: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA; Glomerulonephritis, Membranous; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xiaoqiang Ding

CONTACT

+86-13601968215; ding.xiaoqiang@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 5, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)