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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Obecabtagene autoleucel (obe-cel)
Biological/VaccineObecabtagene autoleucel (obe-cel) given as a single infusion.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Obecabtagene autoleucel (obe-cel)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs))
Time frame
Up to Day 282
To evaluate the safety of obe-cel in participants with refractory forms of progressive multiple sclerosis (PMS)
To evaluate the safety of obe-cel in participants with refractory forms of progressive multiple sclerosis (PMS)
Time frame
Up to end of studySecondary outcomes
1
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
The EDSS is based on a standardized neurological examination focussing on assessment of 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel / bladder and cerebral). The range of the EDSS includes 20 half steps from 0 to 10, with EDSS step 0 corresponding to a completely normal examination and EDSS step 10 to death due to MS.
Time frame
Up to Month 242
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Timed 25-foot Walk Test (T25FWT).
Change from baseline in T25FWT
Time frame
Up to Month 243
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using 9-hole Peg Test (9-HPT)
Change from baseline in 9-HPT
Time frame
Up to Month 244
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Symbol Digit Modalities Test (SDMT)
Change from baseline in SDMT
Time frame
Up to Month 24Sponsors and contacts
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Source ClinicalTrials.gov