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

NCT06926985 | Withdrawn Early Phase 1

• 1 other identifier: 2025002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IgA Nephropathy (IgAN)

Keywords

IgA Nephropathy; CD19 BCMA CAR NK; SLE

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The complete response rate

  52 weeks after infusion

• The partial response rate

  48 weeks after infusion

Study Arms (1)

anti-CD19 BCMA CAR NK cells

EXPERIMENTAL

Biological: anti-CD19/BCMA CAR NK cells

Interventions

anti-CD19/BCMA CAR NK cells BIOLOGICAL

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.

anti-CD19 BCMA CAR NK cells

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 years old and ≤ 70 years old, male or female;
• IgA nephropathy confirmed by pathological biopsy of renal biopsy;
• 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;
• 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

You may not qualify if:

• Subjects with IgA nephropathy with rapidly progressive renal function, pathological manifestations include extensive crescent formation and necrotic vascular lesions in the glomeruli;
• Secondary IgA nephropathy;
• Subjects do not take medication regularly or stop taking medication during treatment;
• 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;
• 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;
• Subjects with acquired and congenital immunodeficiency diseases;
• Subjects with grade III or IV heart failure (NYHA classification);
• History of epilepsy or other central nervous system (CNS) diseases;
• 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;
• History of other primary malignant tumors except:
• Cured non-melanoma skin cancer by surgical excision, for example basal cell carcinoma (BCC) ;
• Cured primary malignant tumors, such as cervical cancer, superficial bladder cancer, breast cancer
• 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;
• Females who are pregnant, lactating, or planning a pregnancy within six months;
• Subjects who have received other clinical trial treatment within 3 months;

Sponsors & Collaborators

• Jieyang People's Hospital: lead

Study Sites (1)

Jieyang People's Hospital

Jieyang, Guangdong, 522000, 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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 15, 2025
• Study Start: July 30, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

CN (1)