Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection

Phase 1 Completed 30 enrolled Thomas Jefferson University Tevogen Bio Inc · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This clinical trial will study the safety and efficacy of COVID-19-specific T cells when given as treatment to adult patients (age ≥ 18 years) with a COVID-19 infection. This immunologic treatment is aimed at patients, who are at high risk of progression due to their advanced age, or other underlying health conditions. The outcomes of patients receiving the T cells (Arm A) will be compared to patients treated with standard of care (Arm B).

Timeline

Start: 2021-09-15
Primary completion: 2022-07-29
Completion: 2023-01-19

Publications

Grosso D, Wagner JL, O'Connor A, Keck K, Huang Y, Wang ZX, Mehler H, Leiby B, Flomenberg P, Gergis U, Nikbakht N, Morris M, Karp J, Peedin A, Flomenberg N. Safety and feasibility of third-party cytotoxic T lymphocytes for high-risk patients with COVID-19. Blood Adv. 2024 Aug 13;8(15):4113-4124. doi: 10.1182/bloodadvances.2024013344.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cytotoxic T Lymphocytes	Cell therapy	100000 cells/kg	Intravenous
Subject	Cytotoxic T Lymphocytes	Cell therapy	300000 cells/kg	Intravenous
Subject	Cytotoxic T Lymphocytes	Cell therapy	1e+06 cells/kg	Intravenous
Subject	Cytotoxic T Lymphocytes	Cell therapy	3e+06 cells/kg	Intravenous

Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection

Summary

Timeline

Publications

Drugs

Indications