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

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 Relapsing Forms of Multiple Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS)

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

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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

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Future Research Use
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