Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
ID04561557

Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System

Led by Tongji Hospital · Updated on 2024-10-30

36

Participants Needed

1

Research Sites

14 weeks

Total Duration

On this page

Sponsors

T

Tongji Hospital

Lead Sponsor

N

Nanjing IASO Biotechnology Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial investigates antibody-mediated inflammatory diseases of the nervous system, which are autoimmune conditions where the body's immune system attacks parts of the nervous system. The study focuses on eight specific diseases including Neuromyelitis Optica Spectrum Disorder, Myasthenia Gravis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Idiopathic Inflammatory Myopathy, Multiple Sclerosis, Autoimmune Encephalitis, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, and POEMS Syndrome. The aim is to evaluate the safety and effectiveness of a novel treatment involving CT103A cells, a form of CAR-T cell therapy targeting B-cell maturation antigen (BCMA) to reduce harmful plasma cells causing these diseases. Participants will receive CT103A cells after a preparatory treatment called lymphodepletion, which involves drugs cyclophosphamide and fludarabine to reduce certain immune cells. The CAR-T cell treatment is given intravenously with different dose levels tested starting from 0.5 million CAR-T cells per kilogram of body weight, potentially increasing to higher or lower doses based on safety and effectiveness observed. The study includes an early-phase design where dosing and safety are carefully assessed in small groups before progressing. Participants will be monitored closely for side effects and treatment impact, including vital signs, physical exams, lab tests, heart function tests, and antibody levels for up to two years after treatment. The main focus is on identifying any dose-limiting toxicities within 28 days of infusion and tracking adverse events for two years. Additional long-term monitoring of the therapy's behavior in the body will continue for up to 15 years. Throughout the study, participants will provide informed consent and undergo various assessments to evaluate safety and treatment effects.

CONDITIONS

Brief Title

Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects aged 18-75 years
  • Diagnosed with relapsed or refractory antibody-mediated inflammatory diseases of the nervous system including NMOSD, Myasthenia Gravis, CIDP, Idiopathic Inflammatory Myopathy, Multiple Sclerosis, Autoimmune Encephalitis, MOGAD, or POEMS Syndrome
  • For NMOSD: AQP4-IgG positive with specific relapse history and immunosuppressant use
  • For Myasthenia Gravis: Positive antibody, MG-ADL score ≥6, MGFA II-IV, prior immunosuppressant use with poor control
  • For CIDP: Positive antibody, INCAT disability scale 2-9, prior first-line therapy with poor control or intolerance
  • For IIM: Diagnosed by EULAR/ACR criteria with active disease signs and prior corticosteroid plus immunosuppressant use or intolerance
  • For Multiple Sclerosis: Diagnosed by McDonald criteria, EDSS 2-7, with relapse or MRI activity after standard therapy
  • For POEMS Syndrome: Diagnosed by IMWG criteria with bone marrow involvement, measurable lesions, VEGF > 2 ULN, ECOG ≥1, ONLS ≥1, and poor/no response to traditional treatments
  • For Autoimmune Encephalitis: Diagnosed by International Criteria, pathogenic antibody positive, prior corticosteroid and immunosuppressant use with poor control, recent onset, and mRS ≥2 or CASE ≥4
  • For MOGAD: Positive serum MOG antibody test, mRS ≥2, prior corticosteroid and immunosuppressant use with poor control
  • Resolved acute toxic reactions to baseline or ≤ grade 1
  • Satisfactory organ function and lab values as specified
  • Blood oxygen saturation > 91%
  • Left ventricular ejection fraction ≥ 50%
  • Expected life expectancy ≥ 12 weeks
  • Willingness to use effective contraception for one year post-infusion
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Inadequate mononuclear cells for CAR-T manufacturing
  • History of autoimmune hemolytic disease
  • History of solid organ transplantation
  • Treatment with alemtuzumab within 6 months or fludarabine/cladribine within 3 months before apheresis
  • Papovaviruses infection
  • Malignancies within 2 years except certain low-risk cancers
  • Chronic active infections including hepatitis B, C, HIV, CMV, or syphilis
  • Uncontrolled Myasthenia Gravis crisis within 2 weeks prior to enrollment
  • Known primary immunodeficiency
  • Severe cardiac dysfunction or recent significant cardiac events
  • Recent cerebrovascular events within 6 months
  • Major surgery within 4 weeks prior to enrollment
  • Serious uncontrolled comorbidities
  • History of thymectomy within 12 months prior to infusion
  • History of psychoactive drug abuse or psychiatric disorders
  • Prone to allergies or serious allergy history
  • Pregnant or lactating women
  • Conditions deemed unsuitable by investigator
  • Pre-infusion criteria not met including low blood counts, oxygen saturation ≤ 91%, uncontrolled arrhythmias, infections requiring IV antibiotics, low creatinine clearance, or maintenance support within one week
  • Cell infusion delayed over 7 days after lymphodepletion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 4 days

Participants undergo leukapheresis to collect cells and receive a 3-day lymphodepletion regimen with cyclophosphamide and fludarabine before receiving CT103A cells.

Daily visits for 3 days prior to treatment infusion

Treatment

Duration - 1 day

Participants receive a single intravenous infusion of CT103A cells at one of three dose levels to assess safety and efficacy.

1 infusion visit (in-person)

Follow-up

Duration - Up to 2 years

Participants are monitored for safety, efficacy, and pharmacodynamics/pharmacokinetics after CT103A infusion.

Regular visits over 2 years for assessments including vital signs, laboratory tests, and imaging

Trial Site Locations

Total: 1 location

1

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

C

Chuan Qin, MD

C

Chuan Qin, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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