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Monoclonal Antibodies
CABA-201 for Myasthenia Gravis
Phase 1 & 2
Recruiting
Research Sponsored by Cabaletta Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 and ≤70 years of age
Diagnosis of seropositive (autoantibodies AChR, MuSK and/or LRP4) or seronegative MG
Must not have
Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
Active infection requiring medical intervention at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days after caba-201 infusion
Awards & highlights
No Placebo-Only Group
Summary
"This trial is looking at a new drug called CABA-201 to see if it is safe and effective for people with generalized myasthenia gravis."
Who is the study for?
This trial is for adults aged 18 to 70 with Generalized Myasthenia Gravis (MG), a condition causing muscle weakness. Participants must have been diagnosed as seropositive or seronegative MG and exhibit certain levels of muscle weakness, according to the MGFA classification.
What is being tested?
The study is testing CABA-201, a new potential treatment for Generalized Myasthenia Gravis. It's an open-label trial, meaning both researchers and participants know what treatment is being given, aimed at assessing how safe and effective this medication is.
What are the potential side effects?
As this summary does not provide specific side effects of CABA-201, generally such trials look out for any adverse reactions ranging from mild symptoms like headaches or nausea to more serious ones affecting organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
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I have been diagnosed with myasthenia gravis.
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I have been diagnosed with Myasthenia Gravis and experience widespread muscle weakness.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a transplant of a solid organ or bone marrow.
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I am currently being treated for an infection.
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I do not have severe or worsening conditions in my kidneys, liver, blood, stomach, lungs, mental health, heart, nerves, or brain.
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I cannot undergo leukapheresis due to health reasons.
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I have serious heart or lung problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days after caba-201 infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after caba-201 infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate incidence and severity of adverse events (AEs)
Secondary study objectives
To characterize the pharmacodynamics (PD)
To characterize the pharmacokinetics (PK)
To evaluate disease-related biomarkers
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CABA-201Experimental Treatment1 Intervention
AChR Antibody-Positive Cohort AChR Antibody-Negative Cohort
Find a Location
Who is running the clinical trial?
Cabaletta BioLead Sponsor
5 Previous Clinical Trials
121 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
24 Patients Enrolled for Myasthenia Gravis
Medical DirectorStudy ChairCabaletta Bio
2,905 Previous Clinical Trials
8,091,457 Total Patients Enrolled
3 Trials studying Myasthenia Gravis
298 Patients Enrolled for Myasthenia Gravis