Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
ConditionProgressive Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAutolus Limited
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Obecabtagene autoleucel (obe-cel)
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov