Browsing by Author "Gupta, Gaurav"

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    Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
    (Wolters Kluwer, 2024) Chandraker, Anil; Regmi, Anil; Gohh, Reginald; Sharma, Akhil; Woodle, E. Steve; Ansari, Mohammed J.; Nair, Vinay; Chen, Ling-Xin; Alhamad, Tarek; Norman, Silas; Cibrik, Diane; Singh, Manpreet; Alper, Arnold; Jain, Divya; Zaky, Ziad; Knechtle, Stuart; Sharfuddin, Asif; Gupta, Gaurav; Lonze, Bonnie E.; Young, Jo-Anne H.; Adey, Deborah; Faravardeh, Arman; Dadhania, Darshana M.; Rossi, Ana P.; Florescu, Diana; Cardarelli, Francesca; Ma, Julie; Gilmore, Sarah; Vasileiou, Spyridoula; Jindra, Peter T.; Wojciechowski, David; Medicine, School of Medicine
    Key Points: *Posoleucel was generally safe, well tolerated, and associated with a greater reduction of BK viremia compared with placebo. *BK viremia reduction occurred coincident with an increase in the circulating frequency of BK virus–specific T cells in posoleucel recipients. *The presence and persistence of posoleucel was confirmed by T-cell receptor variable β sequencing. Background: Kidney transplant recipients with BK virus infection are at risk of developing BK virus–associated nephropathy, allograft rejection, and subsequent graft loss. There are no approved treatments for BK virus infection. Posoleucel is an off-the-shelf, allogeneic, multivirus-specific T-cell investigational therapy targeting BK virus, as well as five other opportunistic viruses: adenovirus, cytomegalovirus, Epstein–Barr virus, human herpesvirus 6, and John Cunningham virus. Methods: In this phase 2, double-blind study, kidney transplant recipients with BK viremia were randomized 1:1:1 to receive posoleucel weekly for 3 weeks and then every 14 days (bi-weekly dosing) or every 28 days (monthly dosing) or placebo for 12 weeks. Participants were followed for 12 weeks after completing treatment. The primary objective was safety; the secondary objective was plasma BK viral load reduction. Results: Sixty-one participants were randomized and dosed. Baseline characteristics were similar across groups. No deaths, graft-versus-host disease, or cytokine release syndrome occurred. The proportion of patients who had adverse events (AEs) judged by the investigators to be treatment-related was slightly lower in recipients of posoleucel: 20% (4 of 20 patients) and 18% (4 of 22) in those infused on a bi-weekly and monthly schedule, respectively, and 26% (5 of 19) in placebo recipients. None of the grade 3–4 AEs or serious AEs in any group were deemed treatment-related. No deaths, graft-versus-host disease, or cytokine release syndrome occurred. Three participants had allograft rejection, but none were deemed treatment-related by investigators. In posoleucel recipients, BK viremia reduction was associated with an increase in the circulating frequency of BK virus–specific T cells, and the presence and persistence of posoleucel was confirmed by T-cell receptor sequencing. Conclusions: Posoleucel was generally safe, well tolerated, and associated with a larger reduction of BK viremia compared with placebo. Limitations of this study include the relatively short duration of follow-up and lack of power to detect significant differences in clinical outcomes.
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    Vaccine for Diabetes-Where Do We Stand?
    (MDPI, 2022-08-22) Chellappan, Dinesh Kumar; Bhandare, Richie R.; Shaik, Afzal B.; Prasad, Krishna; Suhaimi, Nurfatihah Azlyna Ahmad; Yap, Wei Sheng; Das, Arpita; Banerjee, Pradipta; Ghosh, Nandini; Guith, Tanner; Das, Amitava; Balakrishnan, Sarannya; Candasamy, Mayuren; Mayuren, Jayashree; Palaniveloo, Kishneth; Gupta, Gaurav; Singh, Sachin Kumar; Dua, Kamal; Surgery, School of Medicine
    Diabetes is an endocrinological disorder with a rapidly increasing number of patients globally. Over the last few years, the alarming status of diabetes has become a pivotal factor pertaining to morbidity and mortality among the youth as well as middle-aged people. Current developments in our understanding related to autoimmune responses leading to diabetes have developed a cause for concern in the prospective usage of immunomodulatory agents to prevent diabetes. The mechanism of action of vaccines varies greatly, such as removing autoreactive T cells and inhibiting the interactions between immune cells. Currently, most developed diabetes vaccines have been tested in animal models, while only a few human trials have been completed with positive outcomes. In this review, we investigate the undergoing clinical trial studies for the development of a prototype diabetes vaccine.