Neuromuscular Disorders Clinical Trials

WE ARE ENROLING NOW! 

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

 

AURORA: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients with Generalized Myasthenia Gravis (MG)

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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