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RecruitingPhase 1

Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

A Single-arm, Open-label, Phase I Study to Determine the Safety, Tolerability, and Preliminary Efficacy of Obe-cel in Participants With Refractory Progressive Forms of Multiple Sclerosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Obe-cel Administration: If the participant's eligibility for receiving obe-cel infusion is confirmed, the participant is to receive a single obe-cel infusion on Day 1."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether obe-cel is safe and looks for early signs that it may help with progressive multiple sclerosis (MS), a disease that gets worse over time. It is for adults ages 18 to 60 whose MS has not responded to at least 2 medicines meant to change its course. Participants receive chemotherapy to lower certain immune cells, then one obe-cel infusion through a vein, with follow-up for up to 24 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 60 years old when signing the consent form.
  • Have progressive MS.
  • Have received at least 2 medicines meant to change the course of MS.
  • Be willing and able to sign a form agreeing to join the study.
  • Be willing and able to follow the study schedule and rules.
  • Not be pregnant or breastfeeding.

Who can't join

  • Take any medicine that the study does not allow.
  • Have highly active MS.
  • Have another disease in which the immune system attacks the brain or spinal cord.
  • Have an active or uncontrolled infection caused by a fungus, bacteria, or virus.
  • Have a history of cancer, unless cancer-free for at least 24 months.
  • Have had a heart, lung, kidney, liver, or blood-forming stem cell transplant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

CA