Universal STAR-T Cell Injection in Autoimmune Kidney Diseases

NCT07746453 | Not Yet Recruiting

• 1 other identifier: YTS209-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

IgA Nephropathy (IgAN); Primary Membranous Nephropathy

Keywords

IgA Nephropathy; Primary Membranous Nephropathy; CD 19; BCMA; Safety; Efficacy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  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

  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

  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

  From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively

• Changes in serum biomarkers from baseline in IgAN participants

  From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively

• Changes in serum biomarkers from baseline in PMN participants

  From enrollment to the end of treatment at 12 weeks and 24 weeks, respectively

Study Arms (1)

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.

Biological: Universal STAR-T Cell

Interventions

Universal STAR-T Cell BIOLOGICAL

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) .

Universal STAR-T Cell

Eligibility Criteria

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

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• China Immunotech (Beijing) Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital.

Guangdong, Guangzhou, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

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

Central Study Contacts

Xueqing Yu, MD

CONTACT

-8620-83827812 ext. 61420; yuxueqing@gdph.org.cn

Li Fan, MD

CONTACT

8615913106705; fanli@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-07

Locations

CN (1)