NCT04742595

Viral Specific T Cell Therapy for COVID-19 Related Pneumonia

Administration of Expanded, Most Closely HLA Matched SARS-CoV-2-Specific T Cells for the Treatment of COVID-19 in Patients With Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial identifies the feasibility, possible benefits and/or side effects of administering SARS-CoV-2 specific cytotoxic T lymphocytes (CTLs) in treating cancer patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the virus responsible for coronavirus disease 2019 (COVID-19). SARS-CoV-2 Specific CTLs are a type of immune cells that are made from donated blood cells grown in the laboratory and are designed to kill cells infected with SARS-CoV-2 virus. Giving CTLs may help control the COVID-19 in cancer patients.

Detailed description

PRIMARY OBJECTIVE: I. To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific T cell lines generated by ex vivo expansion as therapy of COVID19 pneumonia in cancer patients. SECONDARY OBJECTIVES: I. To obtain preliminary data about the efficacy of administering most closely HLA-matched SARS-COV-2 specific T cell lines generated by ex vivo expansion. II. To assess the persistence of the administered cells in the patients. OUTLINE: Patients receive SARS-COV-2 specific cytotoxic T lymphocytes intravenously (IV) over 30 minutes on day 1. Treatment may repeat every 14 days at investigators' discretion if patient fails to respond, the infection reoccurs, until the viral load becomes negative or until complete resolution of clinical and radiological signs. After completion of study treatment, patients are followed up at 7, 14, 21, 28, and 45 days, and 3 months after each cytotoxic T lymphocyte infusion.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Symptomatic COVID-19 Infection Laboratory-Confirmed

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes	Given IV

Timeline

• Start date: 2020-12-18
• Primary completion: 2024-09-20
• Completion: 2024-09-20
• First posted: 2021-02-08
• Last updated: 2024-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study