IgA Nephropathy (IgAN)NCT07746453
Universal STAR-T Cell Injection in Autoimmune Kidney Diseases
A study testing Universal STAR-T Cell in people with IgA Nephropathy (IgAN) and Primary Membranous Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IgA Nephropathy (IgAN), Primary Membranous Nephropathy
- What is being tested?
- Universal STAR-T Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 1 Oct 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all the following inclusion criteria to be enrolled in this study:
- Age 18-65 years (inclusive), gender (no gender restriction);
- Previous diagnosis of IgA Nephropathy (IgAN) or Primary Membranous Nephropathy (PMN)：
- IgA Nephropathy (IgAN): Renal biopsy confirmed as IgAN, and meets any one of the following criteria:
- 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;
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- Unable to tolerate conventional treatment, may be considered for enrollment after full evaluation by the investigator.
- Primary Membranous Nephropathy (PMN): Renal biopsy confirmed as PMN, and anti-phospholipase A2 receptor antibody (anti-PLA2R) is positive, and meets any one of the following criteria for relapsed or refractory PMN:
- Refractory PMN: Received hormone combined with cyclophosphamide or calcineurin inhibitor (CNI) or rituximab for ≥6 months, and meets any one of the following:(a) Anti-PLA2R persistently high titer >50 RU/mL;(b) Persistent 24-hour urinary protein >3.5 g/d, and reduction <50% during treatment;(c) Unable to tolerate the above immunosuppressive therapy, or discontinued due to severe adverse reactions;
- Relapsed PMN: After achieving complete remission, 24-hour urinary protein re-increased to >3.5 g/d;
- Function of vital organs meets the following requirements:
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- Bone marrow function must satisfy:(a) Neutrophil count ≥1.0×10⁹/L (without colony-stimulating factor treatment within 2 weeks prior to testing, except for disease-induced neutropenia);(b) Hemoglobin ≥60 g/L;(c) Platelet count ≥30×10⁹/L;
- Liver function:(a) ALT ≤3×ULN (elevations due to disease are excluded);(b) AST ≤3×ULN (elevations due to disease are excluded);(c) TBIL ≤1.5×ULN (elevations due to disease are excluded);
- Kidney function: Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² (calculated by CKD-EPI formula);
- Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Prothrombin Time (PT) ≤1.5×ULN;
- Cardiac function: Hemodynamically stable; 4. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use medically accepted contraceptive measures or abstinence during the study and for 24 months after cell infusion; female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and must not be lactating: 5. Voluntarily participate in this clinical study and sign the informed consent form.
Who cannot join
- Subjects who meet any of the following exclusion criteria will be excluded from this study:
- 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;
- Active tuberculosis at screening;
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- Cardiac insufficiency (NYHA functional class >II), unable to tolerate study lymphodepletion and cell reinfusion;
- Subjects with congenital immunoglobulin deficiency;
- History of malignant tumor within the past 5 years that has not yet resolved;
- Positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the detection limit; positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA positive; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test;
- Male and female subjects who plan to conceive during the study period or within 24 months after cell infusion;
- Subjects whom the investigator deems otherwise unsuitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Provincial People's Hospital.
Guangdong, Guangzhou
Xueqing Yu, 020-83827812 ext. 61420, yuxueqing@gdph.org.cn
About this study
Official title: An Exploratory Study to Evaluate the Safety and Efficacy of Universal STAR-T Cell Injection in Subjects With Autoimmune Kidney Diseases
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).
- Being tested
- Universal STAR-T Cell
- Keywords
- IgA Nephropathy, Primary Membranous Nephropathy, CD 19, BCMA, Safety, Efficacy
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal STAR-T CellBiological
There 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) .
| Study group | Role | What they receive |
|---|---|---|
| Universal STAR-T Cell | Experimental | 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) of universal STAR-T cells will be administered to partcipants. Receives: Biological: Universal STAR-T Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: AEs will be observed until 24 weeks after STAR-T cells injection and extended to 104 weeks.
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.
Measured: Within 28 days after START-T cells infusion.
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.
Measured: From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively
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
Measured: From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively
Secondary outcomes (12)
Changes in 24-hour UPCR from baseline in IgAN and PMN participants
24-hour urine sample will be collected and UPCR will be measured.
Measured: From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively
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.
Measured: From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively
Changes in kidney function from baseline in IgAN and PMN participants
eGFR will be measured to evaluate kidney fucntion
Measured: From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively
Changes in serum biomarkers from baseline in IgAN participants
Biomarkers include serum albumin, Gd-IgA1, C3, C4 and Immunoglobulins.
Measured: From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively
Changes in serum biomarkers from baseline in PMN participants
Biomarkers include serum albumin, anti-PLA2R, C3, C4 and Immunoglobulins.
Measured: From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively
Maximum Plasma Concentration of Universal STAR-T Cells (Cmax)
To evaluate the maximum observed plasma concentration of Universal STAR-T Cells
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Time to Reach Maximum Plasma Concentration (Tmax) of Universal STAR-T Cells.
To evaluate the time to reach the maximum observed plasma concentration of Universal STAR-T Cells.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Area Under the Plasma Concentration-Time Curve (AUC) of Universal STAR-T Cells
To evaluate the total systemic exposure to Universal STAR-T Cells over time.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Change in PD Biomarkers
PD Biomarkers include serum serum cytokine concentrations, such as IL-1β, IL-2、IL-6, IL-8, TNF-α, and IFN-γ, using validated ELISA kits
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Changes in B cells in peripheral blood
Evaluation of PD effects of Universal STAR-T Cells via serial quantification of CD19-positive B cells in peripheral blood, expressed as cells per microliter (cells/μL). Measurement will be performed using flow cytometry according to standardized laboratory protocols
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks
Change in plasma cells in peripheral blood
Evaluation of PD effects of Universal STAR-T Cells via serial quantification of plasma cells in peripheral blood, expressed as cells per microliter (cells/μL). Measurement will be performed using flow cytometry according to standardized laboratory protocols.T
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Anti-Drug Antibodies (ADA) against universal STAR-T cells
To evaluate the development of anti-drug antibodies (ADA) against allogeneic universal STAR-T cells in peripheral blood
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, XueQing Yu, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746453
- Sponsor's protocol ID
- YTS209-004
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No