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Cabaletta Bio (CABA)
NASDAQ:CABA
Caba-201
Multiple Sclerosis, Progressive Multiple Sclerosis, Relapsing Multiple Sclerosis (Rms), Progressive Multiple Sclerosis (Pms), Multiple Sclerosis - Relapsing Remitting, Multiple Sclerosis (Relapsing Remitting), Multiple Sclerosis (Ms) - Relapsing-Remitting
Phase I/II
Not Yet Recruiting
RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis
Apr 22, 2025
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Caba-201
Generalized Myasthenia Gravis (Gmg)
Phase I/II
Recruiting
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
Mar 21, 2024
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Caba-201
Systemic Sclerosis, Scleroderma
Phase I/II
Recruiting
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
Mar 19, 2024
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Caba-201 Following Preconditioning With Fludarabine And Cyclophosphamide
Dermatomyositis, Juvenile Dermatomyositis, Immune-Mediated Necrotizing Myopathy, Idiopathic Inflammatory Myopathy, Anti-Synthetase Syndrome, Juvenile Polymyositis, Juvenile Idiopathic Inflammatory Myopathy (Jiim), Juvenile Myositis
Phase I/II
Recruiting
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
Nov 16, 2023
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Caba-201
Lupus Nephritis, Systemic Lupus Erythematosus
Phase I/II
Recruiting
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Oct 23, 2023
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Dsg3-Caart Or Caba-201
Pemphigus Vulgaris
Phase I
Recruiting
A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
Jun 02, 2020
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Cabaletta Bio (CABA) have in its pipeline
CABA is currently developing the following drugs: Caba-201, Caba-201, Caba-201. These drug candidates are in various stages of clinical development as the company works toward FDA approval.