NCT04146285

Brief Summary

This study is a phase I clinical study of the safety, tolerability, and pharmacokinetics of BAT4406F injection in patients with neuromyelitis optica spectrum disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

July 10, 2025

Status Verified

March 1, 2023

Enrollment Period

2.5 years

First QC Date

September 26, 2019

Last Update Submit

July 7, 2025

Conditions

Neuromyelitis Optica Spectrum Disorders

Outcome Measures

Primary Outcomes (7)

  • Dose-limiting toxicity（DLT）

    Safety and tolerability endpoint

    4weeks

  • Maximum tolerated dosed (MTD)

    Safety and tolerability endpoint

    up to 6 months

  • Area under the curve (AUC)

    Pharmacokinetic endpoint

    up to 6 months

  • Maximum serum drug concentration (Cmax)

    Pharmacokinetic endpoint

    up to 6 months

  • Half-life period(t1/2)

    Pharmacokinetic endpoint

    up to 6 months

  • Maximum serum drug time (Tmax)

    Pharmacokinetic endpoint

    up to 6 months

  • CD19+ B lymphocyte ratio

    Pharmacodynamics endpoint

    up to 6 months

Study Arms (1)

BAT4406F

EXPERIMENTAL
Drug: BAT4406F

Interventions

BAT4406FDRUG

Open-label dose escalation starting from 20mg. Route of administration: intravenous infusion.

BAT4406F

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Compliance with the NMOSD diagnostic criteria developed by the 2015 International NMO Diagnostic Team (IPND);
  • years old , male or female;
  • At least 2 relapses occurred within 2 years before screening, or at least 1 relapse within 1 year before screening;
  • Discontinue the immunosuppressive agents such as azathioprine within 28 days before the baseline;
  • EDSS score ≤ 6;
  • Men and women with fertility must agree to use effective methods of contraception during treatment and within 12 months of treatment completion;
  • Agree to participate in the trial and sign the informed consent in writing.

You may not qualify if:

  • Any monoclonal antibody treatment was used within 6 months prior to dosing;
  • Having been treated with anti-CD20 monoclonal antibody;
  • Live vaccine received within 4 weeks before screening;
  • Having participated in another clinical study within 1 month or 5 half-lives of the drug prior to the baseline (whichever is longer);
  • A history of allergies to monoclonal antibodies; severe allergic reaction to certain foods or drugs;
  • Abnormal liver function, kidney function and bone marrow reserve;
  • HIV-positive history or HIV-positive at screening; hepatitis B and/or hepatitis C history or hepatitis B surface antigen-positive at screening; or hepatitis C virus (HCV) antibody positive; treponema pallidum antibody positive when enrolled;
  • History of infections that investigators have identified as unsuitable for testing;
  • Patients with a clear history of heart disease ;
  • Have a history of mental disorders;
  • Pregnant or lactating women, and female subjects who have a positive pregnancy test at screening;
  • None of the investigators or their relatives participating in the study could be enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

  • Yu H, Chen Y, Qi Y, Yang H, Cao G, Yang W, Li S, Yang X, Wang H, Zhang J, Chen X. First-in-Human Study of BAT4406F, an ADCC-Enhanced Fully Humanized Anti-CD20 Monoclonal Antibody in Patients With Neuromyelitis Optica Spectrum Disorders. CNS Neurosci Ther. 2024 Nov;30(11):e70126. doi: 10.1111/cns.70126.

    PMID: 39592888DERIVED

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, TransverseDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesOptic NeuritisOptic Nerve DiseasesCranial Nerve DiseasesDemyelinating DiseasesEye DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Xiangjun Chen

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

  • Jing Zhang

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2019

First Posted

October 31, 2019

Study Start

September 1, 2020

Primary Completion

March 13, 2023

Study Completion

December 25, 2023

Last Updated

July 10, 2025

Record last verified: 2023-03

Locations

CN(1)