SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease

This is an interventional treatment trial for Covid19 Read More

INCLUSION CRITERIA

• Age ≥18 to 65 years. AND
• Proven infection with SARS-CoV-2, defined as detection of SARS-CoV-2 by RT-PCR from nasopharyngeal swab or lower respiratory tract specimen AND
• Hospitalized at the time of enrollment AND
• HLA Matched Family Related donor with recent SARS-CoV-2 infection is at least 10 days out from symptom onset. A negative result for COVID-19 by a diagnostic test is not necessary to qualify the donor AND
• In Stage I or II of disease (mild or moderate) at the time of enrollment (Table 1) AND

• ONE of the following high-risk conditions:

  • Chronic lung disease not requiring oxygen at home prior to admission (including but not limited to COPD, cystic fibrosis, asthma and sickle cell disease); Underlying heart disease (including hypertension); Patients with an acute myocardial infarction within the last 3 months will require cardiology clearance prior to enrollment; Diabetes mellitus (type I or II) ; Obesity (BMI ≥ 30); Immunosuppressed, based on investigator's assessment.

EXCLUSION CRITERIA:

• Stage III disease (severe) at the time of enrollment (see Table 1)
• Lack of an identified eligible HLA family related donor
• No high-risk comorbidities defined in the inclusion criteria (Section 5.1)
• Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of enrollment
• Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL Infusion
• Patients with chronic respiratory failure requiring ventilator support and/or oxygen at home prior to admission are excluded
• Patients with stage D heart failure and/or symptoms at rest are excluded
• Renal function: patients with eGFR or CrCl <30 mL/min/1.73 m2 will be excluded from study entry.
• Liver function: Total bilirubin > 2 mg/dl (unless Gilbert's syndrome) OR ALT/AST > 5 x ULN
• Patients currently listed for transplant or potentially eligible to receive organ transplants are excluded from this study
• Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤50%
• Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of SARS-CoV-2 CTLS.
• Male subjects with female partners of childbearing age who are not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of SARS-CoV-2 CTLS.

• Concurrent use of following medications is prohibited:

  • Steroids (>2 mg/kg/day prednisone equivalent); Immunotherapies within 4 weeks prior to CTL infusion including checkpoint blockade, ATG, Campath, CAR T cells, blinatumomab; Chemotherapy: Tyrosine kinase inhibitors and hydroxyurea must be stopped > 72 hours prior to SARS-COV-2-CTL cell infusion; High dose chemotherapy must be stopped > 2 weeks prior to SARS-CoV-2-CTLs. High dose chemotherapy is defined in this protocol as any cancer directed therapy causing myelosuppression; Pegylated-asparaginase must be stopped > 4 weeks prior to SARS-COV-2-CTL infusion; Intrathecal chemotherapy must be stopped > 1 week prior to SARS-COV-2-CTL infusion (e.g. intrathecal methotrexate); Anti T-cell Antibodies: Administration of any T cell lytic or toxic antibody (e.g. alemtuzumab) within 30 days prior to SARS-CoV-2-CTLs is prohibited.