RecruitingPhase 1Progressive MSNCT071397432024-519552-93-00

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Obecabtagene autoleucel

    B-lymphocyte antigen CD19 binding agent

What it measured

Main measures

  • Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs))

    Up to Day 28

    Safety
  • To evaluate the safety of obe-cel in participants with refractory forms of progressive multiple sclerosis (PMS)

    Up to end of study

    Safety

Other measures (4)

  • To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Expanded Disability Status Scale (EDSS) - Change from baseline in EDSS

    Up to Month 24

    Disability progressionBladder, bowel and sexual function
  • To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Timed 25-foot Walk Test (T25FWT).

    Up to Month 24

    Disability progressionWalking and mobility
  • To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using 9-hole Peg Test (9-HPT)

    Up to Month 24

    Disability progression
  • To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Symbol Digit Modalities Test (SDMT)

    Up to Month 24

    Thinking and memory

Who could take part

Progressive MS · 18 to 60

Inclusion Criteria: * Willing and able to give written informed consent for participation in the study. * Ability and willingness to adhere to the protocol's Schedule of Activities and other requirements. * Participants must be 18 to 60 years of age inclusive at the time of signing the informed consent form. * A female participant is eligible to participate if she is not pregnant or breastfeeding. * Current diagnosis of PMS. * Must have been treated previously with at least 2 disease-modifying therapies. Exclusion Criteria: * Any medications prohibited by the protocol. * Highly active multiple sclerosis. * Diagnosis of another autoimmune central nervous system condition. * Active or uncontrolled fungal, bacterial, viral infection. * History of malignant neoplasms unless disease-free for at least 24 months. * History of heart, lung, kidney, liver transplant or hematopoietic stem cell transplant.

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

Contact details on the registry

About this trial

In the sponsor's words

The main purpose of this study is to evaluate if obe-cel is safe or causes any side effects in adults with refractory progressive MS. The study also plans to assess if obe-cel can show early signs of efficacy in MS. The trial includes only 1 group of participants (single-arm). The study population comprises participants with progressive forms of MS, not responsive to at least 2 disease-modifying therapies. Upon confirmation of study eligibility, participants will receive chemotherapy (used here for lymphodepletion) over 1 to 3 days in preparation for receiving a single obe-cel infusion. Participants will be checked closely in the 28 days following obe-cel treatment. After this, participants will be monitored to evaluate safety and efficacy up to 24 months.

Papers

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    History

      1. Started

        Aug 2025

      2. Main results due

        Aug 2029

      3. Finished

        Aug 2029

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