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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519552-93-00 | EU Trial (CTIS) Number | ||
| 1011413 | Other Identifier | UK IRAS ID |
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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.
This is a Phase 1 study to determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of multiple sclerosis.
The study comprises 3 periods:
Screening Period: From Day -30 to enrolment Treatment Period: From day of enrolment to End of Treatment (EOT) or Day 1 - Participants will be evaluated to confirm eligibility for lymphodepletion, and thereafter receive lymphodepletion to enhance treatment efficacy and cluster of differentiation (CD)19 chimeric antigen receptor (CAR) T cell survival.
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.
Post treatment Period: From Day 1 to End of Study all participants will be followed up for efficacy and safety evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obecabtagene autoleucel (obe-cel) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obecabtagene autoleucel (obe-cel) | Biological | Obecabtagene autoleucel (obe-cel) given as a single infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs)) | Up to Day 28 | |
| 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) | Up to end of study |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Autolus Ltd | Contact | +44 (0)203 911 4385 | clinicaltrials@autolus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Not yet recruiting | Redwood City | California | 94063 | United States |
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Single-arm, single group assignment, open-label
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| Up to Month 24 |
| 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 | Up to Month 24 |
| 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 | Up to Month 24 |
| 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 | Up to Month 24 |
| Hospital Universitario Vall d'Hebron - PPDS | Active, not recruiting | Barcelona | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Recruiting | Valencia | Spain |
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| Addenbrooke's Hospital | Recruiting | Cambridge | United Kingdom |
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| Western General Hospital Edinburgh - PPDSE Edinburgh | Recruiting | Edinburgh | United Kingdom |
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| The National Hospital for Neurology & Neurosurgery | Recruiting | London | United Kingdom |
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| Royal Hallamshire Hospital | Recruiting | Sheffield | United Kingdom |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |