SARS-CoV-2 Specific Cytotoxic T Lymphocytes for the Treatment of COVID-19 in Patients With Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19-Associated Acute Respiratory Distress Syndrome
- COVID-19-Associated Pneumonia
- Hematopoietic and Lymphoid Cell Neoplasm
- Malignant Solid Neoplasm
- Symptomatic COVID-19 Infection Laboratory-Confirmed
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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. SECONDA...
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 patients 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.
Tracking Information
- NCT #
- NCT04742595
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Marin M.D. Anderson Cancer Center