RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in P

RESET-MS: A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Participants With Multiple Sclerosis

WithdrawnPhase 1Phase 2Relapsing and progressiveNCT07006805

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: The study was withdrawn prior to site activation and before enrollment of any participants due to sponsor decision to reprioritize the development portfolio.

What was tested

Treatment tested

  • CABA-201

What it measured

Main measures

  • Primary (Part A: Dose Escalation) incidence and severity of adverse events

    Up to 28 days after CABA-201 infusion

    Safety

  • Primary (Part B: Dose Expansion) incidence of and severity of adverse events in order to confirm the dose(s) of CABA-201

    Up to 28 days after CABA-201 infusion

    Safety

Other measures (8)

  • Part A and Part B: To evaluate the incidence and severity of adverse events

    Up to 156 weeks after CABA-201 infusion

    Safety

  • Part A and Part B: To characterize the pharmacodynamics (PD)

    Up to 156 weeks after CABA-201 infusion

    Immune response

  • Part A and Part B: To characterize the pharmacokinetics (PK)

    Up to 156 weeks after CABA-201 infusion

    How the body handles the medicine

  • Part A and Part B: To evaluate disease related biomarkers

    Up to 156 weeks after CABA-201 infusion

    Blood or spinal fluid markers

  • Part A and Part B: To evaluate the effects of CABA-201 on MS disease activity as measured by Magnetic Resonance Imaging (MRI)

    Up to 156 weeks after CABA-201 infusion

    MRI lesions

  • Part A and Part B: The effects of CABA-201 on MS disease activity as measured by EDSS

    Up to 156 weeks after CABA-201 infusion

    Disability progression

  • Part A and Part B: To evaluate the effect of CABA-201 on use of subsequent MS-related therapy

    Up to 156 weeks after CABA-201 infusion

  • Part A and Part B: To evaluate the effect of CABA-201 on patient reported and health outcomes as measured by SF-36 v2

    Up to 156 weeks after CABA-201 infusion

    Quality of life (reported by participants)

Who could take part

Relapsing and progressive · 18 to 60

Show the full criteria

Inclusion criteria

The main inclusion criteria include the following: * Able to provide informed consent. * Age ≥18 and ≤60 years of age. * Diagnosis of MS per the revised 2017 McDonald criteria (Thompson et al, 2018). * For participants with relapsing forms of MS only (RMS Cohort): 1. Moderate degree of previously accumulated disability as measured by the Expanded Disability Status Scale (EDSS) 2. Documentation of clinical relapse or a positive historical gadolinium (Gd)-enhancing magnetic resonance imaging (MRI) scan prior to Screening 3. Prior treatment with a high-efficacy therapy or prior treatment failure of oral therapies * For participants with progressive forms of MS only (PMS cohort): 1. Moderate Disability as measured by EDSS 2. Presence of abnormal function on protocol specified EDSS Functional Systems Scale 3. Objective worsening of disease prior to Screening while on standard of care therapy * Clinical stability by vital signs assessment at the time of screening

Exclusion criteria

The main exclusion criteria include the following: * History of fulminant MS * Clinically significant concomitant central nervous system pathologies which, in the Investigator's judgement, may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity, including but not limited to: 1. Any history of seizure disorder, even if well-controlled on antiepileptics 2. History of progressive multifocal leukoencephalopathy * Active, inflammatory autoimmune disorder other than MS requiring immunomodulatory therapies a. Positive human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B surface antigen test, or evidence of active or chronic tuberculosis (TB) at Screening or other chronic viral infections as described in the protocol * Use of the following therapies: 1. Any prior or concurrent exposure to mitoxantrone, alemtuzumab, total lymphoid irradiation 2. Cladribine within 1 year of Screening 3. Any investigational agent within 4 weeks or 5 half-lives of Screening, whichever is longer 4. Other pre-specified Disease-Modifying Therapies be discontinued by the time of pre-conditioning or earlier as described in the protocol * Known malignancy or a history of malignancy * Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, or concomitant neurological disease, including severe (requiring medical intervention) and uncontrolled infections * Chronic pulmonary disease * Impaired cardiac function or clinically significant cardiac disease * Prior engineered T cell therapy involving permanent gene modification * Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic stem cell transplant.

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

About this trial

In the sponsor's words

RESET-MS: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Participants with Multiple Sclerosis

Papers

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    History

      1. Started

        Jun 2026

      2. Main results due

        Sept 2028

      3. Finished

        Oct 2029

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