To hear about similar clinical trials, please enter your email below
Trial Title:
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
NCT ID:
NCT06359041
Condition:
Generalized Myasthenia Gravis (gMG)
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
CABA-201
autoimmune disease
anti-CD19 CAR-T therapy
cellular therapy
Myasthenia Gravis
Neuromuscular
Anti-AChR
Anti-LRP4
Anti-MuSK
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CABA-201
Description:
Single intravenous infusion of CABA-201 at a single dose level following preconditioning
with fludarabine and cyclophosphamide
Arm group label:
CABA-201
Summary:
RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in
Participants with Generalized Myasthenia Gravis
Detailed description:
Myasthenia gravis (MG) is a rare autoimmune disorder characterized by autoantibody
responses that cause defective transmission of signals at the neuromuscular junction,
resulting in a distinctive pattern of weakness. Patients with generalized MG (gMG)
typically experience symptoms associated with ocular disease in addition to weakness of
many other voluntary muscle groups, including extremity, bulbar, and respiratory muscles.
MG is considered a classic example of a B-cell mediated autoimmune disease. Currently,
there are no curative treatments for MG. This study is being conducted to evaluate the
safety and efficacy of an investigational cell therapy, CABA-201, that can be given to
patients with gMG. A single dose of CABA-201 in combination with cyclophosphamide (CY)
and fludarabine (FLU) will be evaluated.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥18 and ≤70 years of age
- Diagnosis of MG with generalized muscle weakness meeting criteria as defined by the
MGFA class II, III , IVa, and IVb.
- Diagnosis of seropositive (autoantibodies AChR, MuSK and/or LRP4) or seronegative MG
Exclusion Criteria:
- Contraindication to leukapheresis
- History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide
or any of their metabolites
- Active infection requiring medical intervention at screening
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic,
hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or
cerebral disease, including severe and uncontrolled infections, such as sepsis and
opportunistic infections.
- Concomitant medical conditions that, in the opinion of the investigator, might place
the subject at unacceptable risk for participation in this study, interfere with the
assessment of the effects or safety of the investigational product or with the study
procedures
- Significant lung or cardiac impairment
- Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell
transplant
Other protocol-defined inclusion/exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alpha Clinic
Phone:
949-824-3990
Email:
alphaclinic@uci.edu
Investigator:
Last name:
Ali Habib, MD
Email:
Principal Investigator
Facility:
Name:
UC Davis, Department of Neurology
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Evan Shen
Phone:
916-734-3009
Email:
evshen@ucdavis.edu
Investigator:
Last name:
David Richman, MD
Email:
Principal Investigator
Facility:
Name:
Houston Methodist Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Delrose A Vernon, BS, MBA, CCRP
Phone:
346-238-8226
Email:
davernon@houstonmethodist.org
Investigator:
Last name:
Dr. Sheetal Shroff, MD
Email:
Principal Investigator
Start date:
October 2024
Completion date:
September 2029
Lead sponsor:
Agency:
Cabaletta Bio
Agency class:
Industry
Source:
Cabaletta Bio
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06359041
