Safety Evaluation of CTX112 in Adults with Neurological Autoimmune Disorders
A Phase 1/2 interventional study involving 220 adults with various neurological autoimmune disorders, including progressive MS, was planned to evaluate the safety of CTX112. Participants were to be followed from the infusion up to 24 months, but no results have been posted yet.
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- #MSResearch
- Most relevant to
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- Source
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- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- No results yet
- Outcome
- Not reported
Why it matters
Understanding the safety of CTX112 could be crucial for developing treatments for severe neurological autoimmune disorders, addressing a significant medical need.
What this does not prove
No results are posted, and planned enrollment and endpoints do not indicate outcomes or findings of the study.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 220 · planned enrolment
- Randomised
- Not applicable
- Controlled
- No
- Primary endpoint met
- Not reported
- Relevant MS type
- PPMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Adults aged 18 to 70 with confirmed diagnosis of PMS, relapsing NMOSD, relapsing MOGAD, refractory AIE, and refractory SPS
- Size of effect
- Not reported
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
Supporting passages (15)
study phasePhase: Phase 1, Phase 2
study designStudy type: Interventional
subjectsParticipants: people; ages from 18 Years to 70 Years; sex All
sample sizeEnrollment: 220 participants (estimated)
relevant ms typesConditions: Progressive Multiple Sclerosis (PMS); Neuromyelitis Optica; Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease; Autoimmune Encephalitis; Stiff-Person Syndrome
interventionInterventions: CTX112
primary endpointPrimary endpoints: To evaluate the safety of CTX112 in adult participants with neurological autoimmue disorders, including PMS, relapsing NMOSD, relapsing MOGAD, refractory AIE, and refractory SPS.
follow upFollow-up: From CTX112 infusion up to 28 days post infusion; From CTX112 infusion up to 24 months post-infusion; From CTX112 infusion up to 24 months post-infusion.; From CTX112 infusion up to Month 6, Month 12, Month 18, and Month 24
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
populationConfirmed diagnosis of PMS, relapsing NMOSD, relapsing MOGAD, refractory AIE, and refractory SPS\n\nExclusion Criteria:\n\n1.
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
peer reviewedTrial registry record.
randomizedAllocation: Not applicable
controlledIntervention model: Single group
sample size basisEnrollment: 220 participants (estimated)
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