From:  An update on cellular and molecular treatment of myasthenia gravis

 Ongoing clinical trial to improve the treatment of myasthenia gravis.

Trial IDPhase/StatusAim of the trial
NCT06463587
MyClad
Phase 3, randomized, double-blind, placebo-controlled clinical study
Recruiting
To investigate the sustained efficacy, the need for retreatment, and the long-term safety of a new formulation of oral cladribine as compared with placebo in participants with gMG.
NCT06626919Phase 1 study
Recruiting
To evaluate the safety, tolerability, and preliminary efficacy of anitocabtagene autoleucel, a BCMA-directed CAR-T therapy, in subjects with gMG.
NCT06799247
AURORA
Phase 3, randomized, double blind, placebo-controlled study.
Recruiting
To evaluate the efficacy, safety, and tolerability of Descartes-08, mRNA CAR-T therapy, in patients with gMG.
NCT06359041
RESET-MG
Phase 1/2, open-label, multicenter study
Active, not recruiting
To evaluate the effects of CABA-201, a CAR-T therapy, in patients with gMG.
NCT06704269A Phase I/II study
Recruiting
To assess the safety, efficacy, and cellular kinetics of YTB323, a biological CAR-T therapy, in participants with treatment-resistant gMG.
NCT06456580
UPSTREAM MG
A randomized, double-blind, placebo-controlled Phase 3 study
Recruiting
To evaluate the efficacy and safety of telitacicept in the treatment of gMG.
NCT06193889
KYSA-6
A Phase 2/3, open-label, randomized, controlled, multicenter study
Recruiting
To investigate the effects of KYV-101, an autologous fully human anti-CD19 CAR-T therapy, vs. ongoing standard-of-care immunosuppressive therapy in patients with gMG.
NCT06414954
SYNAPSE-MG
Phase 2 proof-of-concept, dose range finding study
Recruiting
To evaluate the safety and efficacy of 3 dose levels of NMD670 vs. placebo in adult patients with MG with antibodies against AChR or MuSK.
NCT06558279
ADAPT oculus
Randomized, double-blinded, placebo-controlled, Phase 3, parallel-group design study
Active, not recruiting
To evaluate the efficacy and safety of efgartigimod PH20 SC in adult patients with ocular MG.
NCT06106672A Phase 1b/2a First-in-Human (FIH) clinical trial
Recruiting
To assess the safety, tolerability, pharmacodynamics, and efficacy of multiple ascending doses of CNP-106 in MG patients.
NCT06055959
ziMyG
Phase 2/3, open-label study
Recruiting
To assess the pharmacokinetics, pharmacodynamics, safety, tolerability, immunogenicity, and activity of zilucoplan in pediatric study participants with gMG.
NCT06517758A randomized, double-blind, placebo-controlled, multicenter, Phase 3 study
Recruiting
To evaluate efficacy, safety, and tolerability of iptacopan in patients with AChR+ gMG who are on stable standard of care (SOC) treatment with symptom management and immunosuppression in participants aged 18 to 75 years with gMG.
NCT04833894Phase 2/3, open-label, uncontrolled trial
Recruiting
To investigate the pharmacokinetics, pharmacodynamics, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG.
NCT06607627An open-label, single-arm, Phase 3 study
Recruiting
To assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants ages 6 to less than 18 with AChR+ gMG.
NCT05265273An open-label, uncontrolled multicenter Phase 2/3 study
Recruiting
To evaluate the safety and efficacy of an investigational medication, nipocalimab, for the treatment of gMG in children aged 2 to less than 18 years old.
NCT05644561A Phase 3, open-label, single-arm, multicenter study
Active, not recruiting
To characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.
NCT06392386A Phase 2/3, open-label, uncontrolled study
Recruiting
To measure the pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to < 18 years.
NCT04524273A Phase 3, multi-center, randomized, quadruple-blind, placebo-controlled study
Active, not recruiting
To assess the efficacy and safety of batoclimab as induction and maintenance therapy in adult participants with gMG.
NCT06436742Phase 1b study
Recruiting
To assess the safety and tolerability of ARGX-119 in adult participants with DOK7-congenital myasthenic syndromes.
NCT04951622Phase 3, multicenter, randomized, double-blind, placebo-controlled study
Recruiting
To evaluate the efficacy and safety of nipocalimab compared to placebo in participants with gMG.
NCT05403541A Phase 3, multi-center, randomized, quadruple-blind, placebo-controlled study
Active, not recruiting
To assess the efficacy and safety of batoclimab as induction and maintenance therapy in adult participants with gMG.
NCT05070858Phase 3
Recruiting
To test how safe the pozelimab and cemdisiran combination therapy and cemdisiran alone are and how well they work in adult patients with gMG.
NCT06298552A randomized, double-blinded, placebo-controlled, Phase 3, parallel-group design study
Active, not recruiting
To measure the efficacy and safety of efgartigimod compared to placebo in participants with AChR binding antibody (AChR-Ab) seronegative gMG.

gMG: generalized myasthenia gravis; BCMA: B-cell maturation antigen; CAR-T: chimeric antigen receptor T-cell; AChR: acetylcholine receptor; MuSK: muscle-specific kinase.