Chaoqun Mei

Insights on Clinical Development of Cell and Gene Therapy for Rare Diseases—by DahShu Innovative Design Scientific Working Group (IDSWG)

Chenkun Wang, Junrui Di, Mercedeh Ghadessi, Rui Tang et autres

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Efficacy and Safety with Extended Follow-up in a Phase 1 Study of BMS-986393, a G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D)-Targeted CAR T Cell Therapy, in Patients (pts) with Heavily Pretreated Relapsed/Refractory (RR) Multiple Myeloma (MM)

Susan Bal, Larry D. Anderson, Omar Nadeem, Jesús G. Berdeja et autres

Introduction Most pts with MM on current treatments will eventually relapse or fail to respond, including with B-cell maturation antigen (BCMA)-targeting therapies. Pts with RRMM have suboptimal survival rates, which worsen with each new line of treatment; thus, new therapy classes are …

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BMS-986393, a G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D)-Targeted CAR T Cell Therapy, in Patients (pts) with Relapsed/Refractory (RR) Multiple Myeloma (MM) and 1-3 Prior Regimens: Updated Phase 1 Safety and Efficacy Results

Susan Bal, Myo Htut, Jesús G. Berdeja, Larry D. Anderson et autres

Introduction The increasing use of quadruplet induction and monoclonal antibody-based maintenance therapies in the management of MM results in the disease becoming refractory to existing therapy classes relatively early in its course. Therefore, new therapy classes are needed for pts with early …

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OA-08 Safety and Preliminary Efficacy of BMS-986393, a GPRC5D CAR T Cell Therapy, in Patients (pts) With Relapsed/Refractory (RR) Multiple Myeloma (MM) and 1–3 Prior Regimens: Results From a Phase 1 Study

Myo Htut, Omar Nadeem, Jesús G. Berdeja, Larry J. Anderson et autres

Efficacy and Safety of Golcadomide, a Novel Cereblon E3 Ligase Modulator (CELMoD) Agent, Combined with Rituximab in a Phase 1/2 Open-Label Study of Patients with Relapsed/Refractory Non-Hodgkin Lymphoma

Julio C. Chávez, Loretta J. Nastoupil, Franck Morschhauser, Guillaume Cartron et autres

Introduction: Golcadomide is a novel, oral, small-molecule CELMoD ® agent that co-opts cereblon to induce targeted degradation of the transcription factors Ikaros/Aiolos, which are crucial to B-cell malignancy development. We previously reported promising efficacy with a predictable and manageable safety profile of …

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Decentralized clinical trials and rare diseases: a Drug Information Association Innovative Design Scientific Working Group (DIA-IDSWG) perspective

Mercedeh Ghadessi, Junrui Di, Chenkun Wang, Kiichiro Toyoizumi et autres

BACKGROUND: Traditional clinical trials require tests and procedures that are administered in centralized clinical research sites, which are beyond the standard of care that patients receive for their rare and chronic diseases. The limited number of rare disease patients scattered around the …

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The Addition of a Defibrillator to Resynchronization Therapy Decreases Mortality in Patients With Nonischemic Cardiomyopathy

Bethany Doran, Chaoqun Mei, Paul D. Varosy, David Kao et autres

OBJECTIVES: The aim of this study was to determine whether patients with heart failure with reduced ejection fraction (HFrEF) due to nonischemic etiology eligible for cardiac resynchronization therapy (CRT) benefit from an implantable cardioverter-defibrillator (ICD). BACKGROUND: It is uncertain whether CRT with …

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A roadmap to using historical controls in clinical trials – by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG)

Mercedeh Ghadessi, Rui Tang, Joey Tianyi Zhou, Rong Liu et autres

Historical controls (HCs) can be used for model parameter estimation at the study design phase, adaptation within a study, or supplementation or replacement of a control arm. Currently on the latter, there is no practical roadmap from design to analysis of a …

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103: Predictive modeling of postpartum readmission for hypertension: A retrospective study

Ramsey G Larson, Chaoqun Mei, Narmin Mukhtarova, Yu‐Hsin Chen et autres

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Does Daily Self-Weighing (DSW) Compared to Routine Care Impact Postpartum Weight Loss? [27B]

Ali N. Lohr, Kara K. Hoppe, Chaoqun Mei, Kathleen M. Antony

INTRODUCTION: Gestational weight gain not lost during the postpartum period contributes to obesity. eHealth technologies have demonstrated promise in promoting postpartum weight loss. In non-obstetric populations, DSW also demonstrates efficacy. This study examined the impact of remote patient monitoring (telehealth (TH)), inclusive …

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Impact of Degree of Left Ventricular Remodeling on Clinical Outcomes From Cardiac Resynchronization Therapy

Fadi Shamoun, Teresa De Marco, David L. DeMets, Chaoqun Mei et autres

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Prospective crossover clinical trial comparing transdermal with oral phenobarbital administration in epileptic cats

Heidi Barnes Heller, Lauren A. Trepanier, Michelle Robertson, Chaoqun Mei

Objectives The aim of this study was to compare serum phenobarbital concentrations, adverse events and client satisfaction during 14 weeks of transdermal vs oral phenobarbital administration to epileptic cats. Methods This was a prospective, fixed-order, crossover pilot study. Nine client-owned cats with …

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