Neuromuscular Disorders Clinical Trials
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Approach to Neuromuscular Clinical Trials
Our approach to Neuromuscular clinical trials focuses on selecting studies that best serve our patient population, preparing all regulatory and operational requirements before launch, and ensuring smooth, well‑coordinated study visits.
Amyotrophic Lateral Sclerosis (ALS)
COYA-302-CLN-2301 (Subcutaneous Injection)
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study with Additional 24-Week Blinded Active Extension to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS) in adults aged 18-75 years.
Principal Investigator: Sheetal Shroff, MD
Contact: Aramide Balogun | abalogun@houstonmethodist.org | 713.441.6955
Idiopathic Inflammatory Myopathies (IIM)
CAB-2010-002 (CAR-T) 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
Idiopathic inflammatory myopathies (IIMs, or myositis) are a group of rare autoimmune diseases characterized by inflammation and muscle weakness. Though the cause of IIM is not well understood, some subtypes of IIM, including dermatomyositis (DM), anti-synthetase syndrome (ASyS), immune-mediated necrotizing myopathy (IMNM), and juvenile idiopathic inflammatory myopathy (JIIM), are thought to involve B cells that cause the body to attack different tissues in the body. 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 DM, ASyS, IMNM, or JIIM who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated. In adults aged 18-75 years.
Principal Investigator: Bing Liao, MD
Contact: Amelia Nounes | aanounes@houstonmethodist.org | 346.356.3639
Myasthenia gravis (MG)
Novartis YTB323 (Biological CAR-T Cells)
A phase 1/2 Open label study intended to assess safety, efficacy, and cellular kinetics of YTB323 in adults aged 18-65 years with treatment- resistant Generalized Myasthenia Gravis.
Principal Investigator: Ericka Greene, MD
Contact: Jennifer Garrett | jmgarrett@houstonmethodist.org | 346.238.4516
RemGen (RC18G006 Telitacicept) prefilled syringe
A Phase 3 Randomized, Double-Blind, placebo-controlled study with an Open-Label Extension to evaluate the efficacy and safety of telitacicept in the treatment of Generalized Myasthenia Gravis in adult participants aged 18 years and older.
Principal Investigator: Bing Liao, MD
Contact: Samia Saad | ssaad@houstonmethodist.org
Novartis CLOU064O12301 A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis (RELIEVE)
A Phase 3 Randomized, Double-Blind, Placebo-Controlled study to evaluate efficacy, safety and tolerability of Remibrutinib versus placebo in adult participants aged 18-75 years with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.
Principal Investigator: Ericka Greene, MD
Contact: Delrose Vernon | davernon@houstonmethodist.org | 713.441.9484
The AURORA Study is evaluating the safety, tolerability, and efficacy of an investigational mRNA CAR T-cell therapy known as Descartes-08 in adults (aged 18 years and olde) with acetylcholine receptor autoantibody -positive generalized myasthenia gravis. Part 1 of the study will last around 6 months. For eligible participants, Part 2 will last around 8 months.
Principal Investigator: Sheetal Shroff, MD
Contact: Aramide Balogun | abalogun@houstonmethodist.org | 713.441.6955
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