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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Given IV
M D Anderson Cancer Center
Houston, Texas, United States
Assessment of feasibility
Proportion of patients who receive at least one severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific cytotoxic T lymphocytes (CTLs) infusion. Study approach will be considered feasible if at least 50% of the enrolled eligible patients receive one CTLs infusion.
Time frame: Up to 3 months post-infusion
Incidence of adverse events
Will collect adverse events and grade them according to Common Terminology Criteria for Adverse Events version 4.0. Attribution will be assigned based on the relationship to the cell infusion.
Time frame: Up to 3 months post-infusion
Response to cytotoxic T lymphocytes
Defined as extubation for patients who required intubation and mechanical ventilation, reduction in the need of oxygen of 50% or a reduction in the fraction of inspired oxygen (FiO2) below 30% or oxygen discontinuation for patients who are not intubated but require oxygen, or resolution of clinical and radiological signs and symptoms for patients who do not require oxygen. Proportion of patients experiencing response will be computed with associated 95% confidence interval.
Time frame: Up to 2 weeks post-infusion
Overall survival
Will be estimated using the Kaplan-Meier method.
Time frame: From treatment start date to date of death, assessed up to 3 months post-infusion
Relapse free survival (original malignancy)
Will be estimated using the Kaplan-Meier method.
Time frame: From treatment start date to the date of documented disease recurrence or death, assessed up to 3 months post-infusion
Cumulative incidence of coronavirus disease 2019 pneumonia resolution after therapy
Time frame: Up to 3 months post-infusion
Cumulative incidence of grade 2-4 or 3-4 graft versus host disease (GVHD), and chronic GVHD
Will be assessed using the competing risks method. The competing risks will include relapse and death and patients who are still alive without disease progression at end of study will be censored.
Time frame: Up to 3 months post-infusion
All-cause mortality
Time frame: At 28 days post-infusion
Proportion of subjects alive and free of respiratory failure
Time frame: At 28 days post-infusion
Reconstitution of anti-virus immunity
Number of SARS-COV-2 specific T-cells in blood will be determined for each patient.
Time frame: Up to 3 months post-infusion
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