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Breakfree-2

A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants With Autoimmune Neurological Diseases: Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS), or Refractory Myasthenia Gravis (MG).
Running, not recruitingPhase 1Relapsing and progressiveNCT06220201

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Zolacabtagene autoleucel
  • Fludarabine
  • Cyclophosphamide anhydrous

What it measured

Main measures

  • Number of participants with adverse events (AEs)

    Up to week 104

    Safety

  • Number of participants with serious adverse events (SAEs)

    Up to week 104

    Safety

  • Number of participants with adverse events of special interest (AESIs)

    Up to week 104

    Safety

  • Number of participants with laboratory test result abnormalities

    Up to week 104

  • Number of participants with imaging abnormalities

    Up to week 104

  • Number of participants with dose-limiting toxicities (DLTs)

    Up to week 104

    Safety

  • Recommended Phase 2 dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period

    Up to week 104

    Safety

Other measures (12)

  • Number of participants meeting no evidence of disease activity (NEDA) criteria

    Up to week 104

  • Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS)

    Up to week 12

    Disability progression

  • Annualized relapse rate

    Up to week 104

    Relapses

  • Change from baseline in magnetic resonance imaging (MRI) metrics

    Up to week 104

    MRI lesions

  • Number of participants with disability improvement confirmed per EDSS

    Up to week 12

    Disability progression

  • Maximum observed blood concentration (Cmax)

    Up to week 104

    How the body handles the medicine

  • Time of maximum observed blood concentration (Tmax)

    Up to week 104

  • Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

    Up to week 104

    How the body handles the medicine

  • Time to last measurable chimeric antigen receptor (CAR T) concentrations (Tlast)

    Up to week 104

  • Number of participants with at least 2 points improvement for at least 4 weeks in Myasthenia Gravis activities of daily living (MG-ADL) score

    Up to week 26

Who could take part

Relapsing and progressive · 18 to 60

Inclusion Criteria - Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1. i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5. ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months. - Progressive forms of MS - Cohort 2. i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0. ii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS). - Myasthenia Gravis - Cohort 3 i)MGFA classification of II-IV at screening ii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening) iii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics. iv) Has had thymectomy, only if indicated according to current guidelines. Exclusion Criteria * Cohorts 1 and 2: Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in \<240 seconds unless extenuating medical conditions unrelated to MS prohibit this. * Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in \< 150 seconds. * Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome. * Other protocol-defined Inclusion/Exclusion criteria apply.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).

Papers

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    History

      1. Started

        Mar 2024

      2. Main results due

        Jul 2027

      3. Finished

        Jul 2027

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