Elderly or high-risk patients with COVID-19 received 1 of 4 escalating dose levels.
Tevogen Bio has completed enrollment in its phase 1 clinical trial evaluating allogeneic cytotoxic CD8+ T lymphocyte cells in elderly or high-risk patients with COVID-19.
Thus far, no dose-limiting toxicities or signficant treatment-related adverse events have been reported among the 24 participants, some of whom were infected with the Delta and Omicron variants as well as other subvariants of COVID-19. Tevogen previously reported that all patients dosed in the first 3 cohorts experienced resolution of lymphopenia following treatment with the cell therapy.
"Concluding patient enrollment in this trial is an exciting milestone and I believe a promising step forward in the advancement of potential new treatments for high risk patients with COVID-19," said trial principal investigator Dolores Grosso, DNP, CRNP, of Jefferson University Hospitals, in a statement.
Patients eligible for inclusion are elderly or have comorbid conditions including those associated with the heart, lungs, liver, kidneys, hypertension, diabetes, cancer, or obesity that put them at higher risk for infection-related complications. Importantly, patients must express the HLA A*02:01 allele that is in common with the cell therapy product in order to be eligible to receive the intravenous therapy.
Patients enrolled received 1 of 4 dose levels: 1 x 105/kg, 3 x 105/kg, 1 x 106/kg, and 3 x 106/kg. Following 4 days of observation in the hospital, patients are discharged home where they will be monitored remotely over a 14-day period, including taking their own blood pressure, temperature, and oxygen levels. Patients will also provide blood samples at 7, 14, and 28 days and 2, 3, and 6 months post-treatment. Patients in the control arm will be monitored remotely by study personnel in their homes for the 14-day period, and can be treated with any standard or experimental COVID-19 therapy.
Primary outcome measures include safety-related end points such as infusion reactions, grade 4 adverse events, graft versus host disease, marrow aplasia, neurotoxicity and/or cytokine release syndrome. Secondary end points include COVID-19 viral load, cell persistence following infusion, the development of endogenous COVID-19-specific T cells and/or antibodies, as well as quality of life end points such as the need for supplemental oxygen, the ability to return to work, fatigue, blood pressure support, performance status, grade of dyspnea, and survival up to 6 months post-treatment.
"Completing this trial will allow us to proceed quickly with further testing of this product in a variety of additional patient groups, including those suffering from Long COVID," said Neal Flomenberg, MD, Tevogen's chief scientific officer.
Notably, TVGN-489 targets multiple internal and external proteins across the viral genome that are preserved regardless of variant since the cell therapy is not limited to the spike protein, which is the target of current vaccines and monoclonal antibodies.