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Not yet recruitingNCT06561009Updated May 30, 2025

Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder

A Phase 1/2 interventional study of Anti-BAFFR CART in Neuromyelitis Optica Spectrum Disorder, sponsored by Tianjin Medical University General Hospital. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by Tianjin Medical University General Hospital · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
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Study summary

This is an open-label, single-arm, dose-escalation study in up to 20 participants with relapsed/refractory Neuromyelitis Optica Spectrum Disorders (NMOSD). The aim is to evaluate the safety and efficacy of the treatment with BAFFR CART.

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Conditions studied

  • Neuromyelitis Optica Spectrum Disorder

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In context

Neuromyelitis Optica

162 studies on the registry are indexed under Neuromyelitis Optica; 72 are open to participants now.

This study's planned enrollment of 20 is below the median of 25 across 97 interventional studies indexed under Neuromyelitis Optica.

Browse Neuromyelitis Optica studies →

Lead sponsor

Tianjin Medical University General Hospital is the lead sponsor of 71 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female subjects aged 18-60 years;
  2. Patients must be diagnosed as AQP4-IgG-positive NMOSD;
  3. At least one immunosuppressant has been used for over a year with poorly controlled symptoms;
  4. Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.
  5. Subjects and their partners must be willing to use effective and reliable methods of contraception, devices or medicines, within one year before BAFFR CART cells infusion.
  6. Subjects must provide written informed consent before the study begins and comply with the requirements of the study protocol.

Exclusion criteria

Exclusion Criteria:

  1. Subjects have received B cell deletion treatment within 6 months before screening;
  2. Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.
  3. Subjects with Papovaviruses infection.
  4. Subjects have received live attenuated vaccine vaccination within 8 weeks before screening; or plan to receive live vaccine vaccination within 8 weeks after treatment;
  5. History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.
  6. Pregnant or lactating women.
  7. Subjects with severe heart, liver, kidney or bone marrow function disorder.
  8. Allergic constitution or a history of severe allergies.
  9. Subjects with conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Participant Group

    BAFFR CART cells

    Drug: Anti-BAFFR CART

Interventions

  • DrugAnti-BAFFR CART

    Anti-BAFFR CART

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What researchers measure

Primary outcomes

  1. Incidence of dose-limiting toxicity (DLT)

    Incidence of dose-limiting toxicity (DLT) will be evaluated within the first 28 days following BAFFR CART cells infusion.

    Time frame: Up to 28 days

  2. Incidence and severity of adverse events

    Adverse events will be evaluated following the chemotherapy preparative regimen and infusion of BAFFR CART cells within the first 28 days.

    Time frame: Up to 28 days

Secondary outcomes

  1. Proportion of BAFFR CART cells in peripheral blood

    The proportion of BAFFR CART cells in peripheral blood will be detected after infusion.

    Time frame: Up to 1 years

  2. Annualized relapse rate (ARR)

    ARR is defined as the number of attacks divided by the total participant-years after infusion.

    Time frame: Up to 1 years

  3. Changes of B cell levels in bone marrow and peripheral blood

    The changes of B cell levels in bone marrow and peripheral blood after BAFFR CART infusion.

    Time frame: Up to 1 years

  4. Changes of AQP4 antibody titers

    Changes of AQP4 antibody titers from baseline over 1 year after BAFFR CART infusion.

    Time frame: Up to 1 years

  5. Changes of cytokine in peripheral blood

    Changes of cytokine(including IL-6, IFN-γ, TNF-α, and serum BAFF) in peripheral blood from baseline over 1 year after BAFFR CART infusion.

    Time frame: Up to 1 years

  6. Changes of Expanded Disability Status Scale (EDSS) score

    Participant will be considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.

    Time frame: Up to 1 years

  7. Changes of visual acuity

    Corrected visual acuity is determine by Snellen E chart held at a distance of 5 meters.

    Time frame: Up to 1 years

  8. Accumulated total active MRI lesions

    The changes of T2 lesions and/or enhancing T1 Lesions as detected by brain Magnetic Resonance Imaging (MRI).

    Time frame: Up to 1 years

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06561009
Lead sponsor
Tianjin Medical University General Hospital
Responsible party
Qiang Liu (Department of Neurology, Tianjin Medical University General Hospital) — Principal investigator
First posted
Aug 19, 2024
Start date
Dec 1, 2025 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
May 30, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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