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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

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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after caba-201 infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after caba-201 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate incidence and severity of adverse events (AEs)
Secondary outcome measures
To characterize the pharmacodynamics (PD)
To characterize the pharmacokinetics (PK)
To evaluate disease-related biomarkers
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CABA-201Experimental Treatment1 Intervention
AChR Antibody-Positive Cohort AChR Antibody-Negative Cohort

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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
2,834 Previous Clinical Trials
8,079,768 Total Patients Enrolled
3 Trials studying Myasthenia Gravis
298 Patients Enrolled for Myasthenia Gravis
~8 spots leftby Sep 2029
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