No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Autolus Limited · Industry
Who this trial is looking for
This trial is looking for adults with progressive multiple sclerosis that has not responded to previous treatments. Participants will receive chemotherapy followed by a single infusion of obe-cel and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 60 years old.
I am willing to provide written consent to participate.
I have been diagnosed with progressive multiple sclerosis.
I have been treated with 2 previous disease-modifying therapies.
I am not pregnant or breastfeeding.
You may not be able to join if
I have highly active multiple sclerosis.
I have another autoimmune central nervous system condition.
I have an active or uncontrolled infection.
I have a history of cancer unless disease-free for at least 24 months.
I have had a heart, lung, kidney, or liver transplant.
I have taken medications that are prohibited by the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 t…
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.
Trial Locations
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City
State
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Status
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 con…
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.
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