Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT07275736

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

Led by Juventas Cell Therapy Ltd. · Updated on 2026-03-05

18

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

J

Juventas Cell Therapy Ltd.

Lead Sponsor

B

Beijing Tiantan Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients willing to sign informed consent
  • Aged 18 to 75 years, any gender
  • Diagnosed with relapsed/refractory antibody-mediated inflammatory neurological diseases with CD19+ B cells
  • Meet specific diagnostic criteria and disease activity for one of these: NMOSD, myasthenia gravis, CIDP, multiple sclerosis, autoimmune encephalitis, or MOG antibody-related disease
  • Proper organ function based on blood counts, coagulation, liver, kidney, and lung criteria
  • Allowed to use low-dose glucocorticoids (prednisone 10mg or equivalent) during the study
  • Fertile participants agree to use effective contraception during treatment and for 24 months after
  • Female participants of childbearing potential have negative pregnancy tests at screening
Not Eligible

You will not qualify if you...

  • Current medical or neurological conditions affecting assessment such as dementia, schizophrenia, bipolar disorder, major depression, brain injury, or substance abuse
  • Pregnant or breastfeeding
  • Prior organ or hematopoietic stem cell transplantation
  • Recent thrombosis or organ infarction within 6 months
  • Active connective tissue diseases needing non-hormonal immunosuppressants
  • Active infections including sepsis, bacteremia, mycosis, uncontrolled pulmonary infections, or tuberculosis
  • Positive for hepatitis B, hepatitis C, HIV, syphilis, or with high EBV or CMV viral loads
  • Major surgery within 4 weeks before screening
  • Malignant tumors within 5 years except low-risk curable tumors
  • Significant heart conditions including low ejection fraction, uncontrolled hypertension, severe heart failure, serious arrhythmias, recent heart surgery, or other unsuitable heart diseases
  • Received live vaccine within 6 weeks before screening
  • Participation in other interventional clinical trials or recent active investigational drug treatments
  • Known allergy to study drug components
  • Previous CAR-T cell therapy
  • Other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, China

Actively Recruiting

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Research Team

D

Decai Tian

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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