Viral Specific T Cell Therapy for COVID-19 Related Pneumonia

Inclusion Criteria:

• Patients age 18 years or older with COVID-19 related infection, defined as patients with a positive SARS-CoV-2 positive reverse transcriptase polymerase chain reaction (RT-PCR) test (bronchoalveolar lavage [BAL], nasal or pharyngeal) within 2 weeks of enrollment and respiratory symptoms (e.g., cough, shortness of breath, chest pain, hemoptysis, nasal congestion, rhinorrhea, anosmia).

• Immunocompromised patient with cancer defined as:

  • Recipients of an stem cell transplantation
  • Patients with hematological malignancies who have been in minimal residual disease (MRD)-negative complete remission (CR) for less than 3 years
  • Patients with hematological malignances who have received chemotherapy, targeted therapy or immunotherapy within 6 months prior enrollment and who are not planned to receive additional therapy for at least 6 weeks after the infusion. All non-hematological toxicity from prior therapy must have been recovered to grade II or less prior enrollment
  • Patients organ solid malignances who have received chemotherapy, targeted therapy or immunotherapy within 6 months prior enrollment and who are not planned to receive additional chemotherapy, targeted therapy or immunotherapy for at least 6 weeks after the infusion. All toxicity from prior therapy must have been recovered to grade II or less prior enrollment
  • Patients with hematological malignancies who have been in MRD-negative CR for more than 3 years and have a peripheral blood CD4 count < 200 x 10^9cells/liter
  • Patients with organ solid malignancies who received chemotherapy, targeted therapy or immunotherapy more than six months prior enrollment and have a peripheral blood CD4 count < 200 x 10^9cells/liter
• 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 prednisone > 0.1 mg/kg/day or equivalent at time of enrollment, 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 uncontrolled infections other than COVID-19: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection
• Karnosky < 70 prior to SARS-COV-2 infection
• Active acute graft versus host disease (GVHD) grade >= 2
• Patients with primary lung cancer not in remission and patients with existing lung metastasis of solid organ tumors