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Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

NCT07139743

RecruitingPhase 1

Sponsor: Autolus Limited

Conditions: Progressive Multiple Sclerosis

Interventions: Obecabtagene autoleucel (obe-cel)

Countries: United States, Spain, United Kingdom

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 highly effective 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.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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.
Locations (7)
  • Redwood City, California, United States
  • Barcelona, Spain
  • Valencia, Spain
  • Cambridge, United Kingdom
  • Edinburgh, United Kingdom
  • London, United Kingdom
  • Sheffield, United Kingdom