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A Study of CNCT19 in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases | Clinical Trials | Clareo Health

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A Study of CNCT19 in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases

An Exploratory Clinical Study on the Safety and Efficacy of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Autoimmune Neurological Diseases

NCT07275736•Juventas Cell Therapy Ltd.

View on ClinicalTrials.gov

Summary

This study is a single-arm, open-label, non-randomized clinical trial aimed at evaluating the safety, tolerability and preliminary efficacy of CNCT19 cell injection in the treatment of patients with relapsed/refractory Neurological Autoimmune Diseases.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients who are willing to sign the informed consent form;
•2. Aged 18-75 years, male or female;
•3. 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:
•* Neuromyelitis optica spectrum disorder (NMOSD): Comply with the diagnostic criteria for NMOSD of the International panel for NMO diagnosis (IPND) in 2015 and meet the following requirements:
•1. aquaporin 4 (AQP4) -IgG positive
•2. At least one immunosuppressant has been used for more than one year and the symptoms have not been well controlled;
•3. EDSS score ≤8 points;
•4. 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.
•* Myasthenia gravis (MG): MG subjects who meet the MGFA classification II-IV as defined by the 2020 American Myasthenia Gravis Foundation (MGFA) diagnostic criteria and satisfy the following requirements:
•1. AChR-Ab serum positive or MuSK antibody positive;
+25 more criteria

Exclusion Criteria

•1. 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.
•2. Pregnancy or breastfeeding;
•3. Have received organ or hematopoietic stem cell transplantation in the past;
•4. There has been a history of new thrombosis or organ infarction within the past six months;
•5. Patients diagnosed with active connective tissue diseases and requiring non-hormonal immunosuppressants/modulators for treatment;
•6. Combined with active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infection and active tuberculosis, etc.);
•7. 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.
•8. Having undergone major surgery that was evaluated by the researcher as unsuitable for inclusion within 4 weeks prior to screening;
•9. Other malignant tumors that have occurred or are currently present within the five years prior to screening are excluded, except for those with negligible risk of metastasis or death and curable tumors, such as well-treated cervical carcinoma in situ and basal cell carcinoma of the skin.
•10. The patient's heart meets any of the following conditions:
+12 more criteria

Locations (1)

Beijing Tiantan Hospital

Beijing, China

Key Dates

Start Date

March 1, 2025

Primary Completion Date

June 1, 2027

Completion Date

June 1, 2029

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Neurological Autoimmune Diseases

Interventions

CNCT19 cell injection

BIOLOGICAL

Contacts

Decai Tian

CONTACT

8610-59976585 decaitian@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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