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A Phase 1 Study of CD19-targeted NEX-T CAR T Cells in Participants with RMS or PMS or RMG

UCI Specialty Area: Neurology
Principal Investigator: Michael Sy
Official Title: 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) (Breakfree-2)
A Study On:
Multiple Sclerosis MS

Study Description

The study will consist of 2 parts: a dose escalation (Part A) and a dose expansion (Part B).

The dose escalation (Part A) will evaluate the safety, tolerability, and pharmacokinetics of

increasing doses of CC-97540 in a single administration to establish the RP2D for dose

expansion. The dose expansion (Part B) will further evaluate the safety,

PK/pharmacodynamics (Pd), and preliminary efficacy of CC-97540 at the RP2D(s). One or

more doses may be chosen as preliminary RP2D(s) for further evaluation in Part B. A Phase

2 study expansion cohort may be initiated upon evaluation of available safety, PK,

pharmacodynamic, and preliminary efficacy data from the dose escalation and dose expansion

portions of this study. The Phase 2 study expansion cohort would be introduced via a protocol

amendment once appropriate supportive data have been generated. The time on study will be

composed of 3 periods: Pre-treatment, Treatment, and Post-treatment Follow-up.

Eligibility

NOTE: This is not a comprehensive list of inclusion and exclusion criteria.

Non-Comprehensive List of Inclusion Criteria for Cohort 1, Relapsing forms of MS (RMS):

  • Expanded Disability Status Scale (EDSS) greater than or equal to 3.0 and less than or equal to 5.5.
  • Diagnosis of MS according to the 2017 McDonald Criteria with a relapsing-remitting course of disease or an initial relapsing-remitting course prior to conversion to aSPMS.
  • Within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months (anti-CD20 monoclonal antibody therapy, cladribine, natalizumab, oralemtuzumab), must have at least one of the following documented: Clinical MS Relapse, greater than or equal to 1 gadolinium-enhancing lesion on brain or spinal cord MRI, or greater than or equal to 1 new T2 lesion on brain spinal cord MRI.

Non-Comprehensive List of Inclusion Criteria for Cohort 2, Progressive Forms of MS (PMS):

  • Participants with PPMS or iSPMS must have EDSS at screening greater than or equal to 3.0 and less than or equal to 6.0
  • Diagnosis of PPMS based on 2017 McDonald criteria for diagnosis of multiple sclerosis in patients with a disease course characterized by progression from onset, including: duration from onset of progressive MS symptoms less than 15 years if screening EDSS score greater than 5.0 OR less than 10 years if screening EDSS score less than or equal to 5.0, and elevated IgG index and/or OCB (historical or at Screening), Treatment-resistant PPMS is defined as Participant must have at least 6 months of treatment with ocrelizumab and must have demonstrated an inadequate response to ocrelizumab. EDSS progression of greater than or qeual to 1 point for participants with

EDSS less than 5.5 at Screening or greater than or equal to 0.5 points for participants with EDSS of greater than or equal to 5.5 at Screening in the 2 years prior to study screening, in the absence of clinical activity or Gd+ T1 lesion OR a written narrative reflecting evidence of comparable clinical disability progression in the previous 2 years, based on neurological exams, functional exams, or other participant-reported functional decline (if documented EDSS scores are not available) and confirmed by adjudication.

OR

Diagnosis of MS according to the 2017 McDonald Criteria with an initial relapsing-remitting course prior to conversion to iSPMS documented as: EDSS progression of greater than or equal to 1 point for participants with EDSS less than 5.5 at Screening or greater than or equal to 0.5 points for participants with EDSS of greater than or equal to 5.5 at Screening in the 2 years prior to study screening, in the absence of clinical activity or Gd+ T1 lesion OR a written

narrative reflecting evidence of comparable clinical disability progression in the previous 2 years, based on neurological exams, functional exams, or other participant-reported functional decline (if documented EDSS scores are not available) and confirmed by adjudication.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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