Anti-SARS Cov-2 T Cell Infusions for COVID 19

Summary

This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.

Timeline

Start

2020-11-04

Primary completion

2021-10-12

Completion

2021-10-12

Outcome

Outcome not reported

Stopped (Enrollment): “Due to trial's eligibility criteria and the low census of hospitalized COVID-19 patients meeting eligibility criteria, the Sponsor will be unable to enroll a meaningful number of patients in this single-center trial in a reasonable time frame.”

Publications

• Vasileiou S, Hill L, Kuvalekar M, Workineh AG, Watanabe A, Velazquez Y, Lulla S, Mooney K, Lapteva N, Grilley BJ, Heslop HE, Rooney CM, Brenner MK, Eagar TN, Carrum G, Grimes KA, Leen AM, Lulla P. Allogeneic, off-the-shelf, SARS-CoV-2-specific T cells (ALVR109) for the treatment of COVID-19 in high-risk patients. Haematologica. 2023 Jul 1;108(7):1840-1850. doi: 10.3324/haematol.2022.281946.

Drugs

Indications