Not Yet RecruitingEarly Phase 1

A Study of HY001N in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases

15 participantsStarted 2025-12-30

Plain-language summary

This study is a single-arm, open-label, non-randomized clinical trial aimed at evaluating the safety, tolerability and preliminary efficacy of HY001N cell injection in the treatment of patients with relapsed/refractory Neurological Autoimmune Diseases.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patients who are willing to sign the informed consent form;
✓. Aged 18-75 years, male or female;
✓. At screening, subjects with relapsed/refractory antibody-mediated inflammatory neurological diseases without effective treatment, the expression of CD19+ B cells in peripheral blood and meeting the special criteria for different indications include:
✓. aquaporin 4 (AQP4) -IgG positive
✓. At least one immunosuppressant has been used for more than one year and the symptoms have not been well controlled;
✓. EDSS score ≤8 points;
✓. There must be at least two relapses within 24 months prior to screening or at least one relapse within the past 12 months, and the relapses should be stable for at least 4 weeks.
✓. AChR-Ab serum positive or MuSK antibody positive;

Exclusion criteria

✕. Current medical conditions or neurological disorders that may affect the effectiveness assessment, such as dementia, schizophrenia, bipolar disorder, major depressive disorder, history of multiple traumatic brain injury, current alcohol/drug abuse or dependence, or alcohol/drug dependence within the past two years.
✕. Pregnancy or breastfeeding;
✕. Have received organ or hematopoietic stem cell transplantation in the past;
✕. There has been a history of new thrombosis or organ infarction within the past six months;
✕. Patients diagnosed with active connective tissue diseases and requiring non-hormonal immunosuppressants/modulators for treatment;
✕. Combined with active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infection and active tuberculosis, etc.);
✕. Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis Be antigen (HBeAg); Positive hepatitis Be antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab), and HBV-DNA copy number greater than the measurable lower limit; Positive for hepatitis C (HCV) antibody Positive for human immunodeficiency virus (HIV) antibody; Those who test positive for syphilis (TP); The copy numbers of EBV-DNA and CMV-DNA are greater than the measurable lower limit.
✕. Having undergone major surgery that was evaluated by the researcher as unsuitable for inclusion within 4 weeks prior to screening;

What they're measuring

Number of participants with dose-limiting toxicities (DLTs)

Timeframe: Up to 28 days after infusion

Number of participants with adverse events (AEs)/serious adverse events (SAEs)

Timeframe: up to Month 36

Trial details

NCT IDNCT07265206

SponsorJuventas Cell Therapy Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Neurological Autoimmune Diseases trials