An Exploratory Clinical Study of Anti-CD19/BCMA Chimeric Antigen Receptor NK Cell Injection in the Treatment of IgA Nephropathy

An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD19/BCMA Chimeric Antigen Receptor NK Cell Injection in the Treatment of IgA Nephropathy

A single arm, open-label pilot study is designed to evaluate the safety and effectiveness of anti-CD19/BCMA CAR NK cells (KN5601) in patients with IgA nephropathy

Study Overview

• Status: Withdrawn
• Conditions: IgA Nephropathy (IgAN)
• Intervention / Treatment: Biological: anti-CD19/BCMA CAR NK cells

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Jieyang, Guangdong, China, 522000
      • Jieyang People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: ≥ 18 years old and ≤ 70 years old, male or female;
2. IgA nephropathy confirmed by pathological biopsy of renal biopsy;
3. All females of childbearing potential must use effective contraception during treatment and for 90 days after the last dose of treatment. In addition, subjects must not donate eggs during the study and for at least 90 days after the last dose of treatment;
4. Urine total protein/urine creatinine ratio (UPCR) ≥ 500 mg/g and estimated glomerular filtration rate (eGFR) > 20 ml/min/1.73m2 during the screening period

Exclusion Criteria:

1. Subjects with IgA nephropathy with rapidly progressive renal function, pathological manifestations include extensive crescent formation and necrotic vascular lesions in the glomeruli;
2. Secondary IgA nephropathy;
3. Subjects do not take medication regularly or stop taking medication during treatment;
4. Individuals with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;
5. Subjects with active infection (except simple urinary tract infection and bacterial pharyngitis), or currently receiving intravenous antibiotic treatment, or subjects who have received intravenous antibiotic treatment within 1 week before KN5601 infusion;
6. Subjects with acquired and congenital immunodeficiency diseases;
7. Subjects with grade III or IV heart failure (NYHA classification);
8. History of epilepsy or other central nervous system (CNS) diseases;
9. History of severe herpes infection, such as herpes encephalitis, ocular herpes, or disseminated herpes; signs of herpes or varicella-zoster virus infection (especially chickenpox, herpes zoster) within 12 weeks prior to screening;
10. History of other primary malignant tumors except:
11. Cured non-melanoma skin cancer by surgical excision, for example basal cell carcinoma (BCC) ;
12. Cured primary malignant tumors, such as cervical cancer, superficial bladder cancer, breast cancer
13. Has a history of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urinary, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other significant disease that precludes KN5601 administration (as determined by the investigator), except IgA nephropathy;
14. Females who are pregnant, lactating, or planning a pregnancy within six months;
15. Subjects who have received other clinical trial treatment within 3 months;
16. Subjects who have received B cell-targeted drug therapy within 1 months before enrollment;
17. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria;
18. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anti-CD19 BCMA CAR NK cells	Biological: anti-CD19/BCMA CAR NK cells; Patients will receive Fludarabine and Cyclophosphamide on day -5, -4, and -3. Multiple doses of anti-CD19/ BCMA CAR NK cells will infused using the dose-escalation strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Dose-Limiting Toxicity (DLT)	To characterize the safety of CD19 CAR NK Cells (KN5601) for IgA Nephropathy	up to 52 weeks after infusion
Incidence of Treatment Emergent Adverse Events (TEAEs)	To characterize the safety of CD19 CAR NK Cells (KN5601) for IgA Nephropathy	up to 52 weeks after infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The complete response rate	To characterize the efficacy of CD19 CAR NK Cell (KN5601) for for IgA Nephropathy	52 weeks after infusion
The partial response rate	To characterize the efficacy of CD19 CAR NK Cell (KN5601) for for IgA Nephropathy	48 weeks after infusion

Collaborators and Investigators

• Sponsor: Jieyang People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: SLE; IgA Nephropathy; CD19 BCMA CAR NK
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: 2025002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No