Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)

Summary

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).

Timeline

Start

2021-03-18

Primary completion

2024-01-30

Completion

2024-01-30

Outcome

Missed primary endpoint

Stopped: “Study discontinued as DSMB determined it was futile. No safety concerns were noted.”

registry analysis (superiority test); Posoleucel (ALVR105) vs Placebo; p = 0.6253; Hazard Ratio (HR) 0.92 (95% CI 0.55 to 1.55); Log Rank NCT04390113 ↗

Publications

• Background Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
• Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Posoleucel	Cell therapy	2 ml	Other
Subject	Posoleucel	Cell therapy	4 ml	Other

Indications