SARS-CoV-2 Specific Immune Cells (Cytotoxic T Lymphocytes) for the Treatment of COVID-19 in Patients with Cancer

Inclusion Criteria

• Immunocompromised patients with hematological malignances and diagnosis of COVID-19 > 3 weeks prior to study entry, treated with at least one standard of care (SOC) therapy (i.e., remdesivir, monoclonal antibody [bebtelovimab or newer one], paxlovid, molnupiravir, corticosteroids, other emergency use authorization [EUA] or Food and Drug Administration [FDA]-approved therapies) with progression of symptoms in the following 14 days after treatment started, of at least 1 category on the 8 ordinal category on the 8 ordinal category World Health Organization (WHO) scale, or CT chest/chest x-ray (CXR) shows progression of pneumonia or increase oxygen requirements of at least 2 liters from baseline. Patients should not show signs of improvement before enrollment. * World health organization (WHO) scale: ** Not hospitalized and no COVID-19 related symptoms; ** Not hospitalized, with COVID-19 related symptoms; ** Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons); ** Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to COVID-19); ** Hospitalized, requiring any supplemental oxygen by nasal cannula; ** Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; ** Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and ** Death.
• Immunocompromised patient with hematological malignances is defined as: * Recipients of an allogeneic stem cell transplantation or other form of cell therapy, for example chimeric antigen receptor (CAR) T-cell therapy * Patients with hematological malignancies who have been in minimal residual disease (MRD)-negative complete response (CR) for less than 3 years from the completion of their last treatment * Patients with hematological malignancies who have been in MRD-negative CR for more than 3 years from the completion of their last therapy and have a peripheral blood CD4 count < 200 x 10^9 cells/liter * Patients with hematological malignances who are not in MRD-negative CR and are not expected to require anticancer treatment for at least 28 days after the CTLs infusion
• English and non-English speaking patients
• Written informed consent and/or signed assent from patient, parent or guardian
• Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study
• Willingness to comply with the study protocol requirements

Exclusion Criteria

• Patients receiving systemic steroids at time of enrollment (physiological substitutive therapy s allowed), or who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment
• Patients with other infections other than COVID-19
• Active acute or chronic graft versus host disease (GVHD)
• Active acute graft versus host disease (GVHD) grade >= 2
• Patients receiving immunosuppressive therapy
• Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures