Status:
UNKNOWN
SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
Lead Sponsor:
New York Medical College
Collaborating Sponsors:
Children's Hospital of Philadelphia
Medical College of Wisconsin
Conditions:
Covid19
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The 2019 Severe Acute Respiratory Syndrome (SARS) is a global pandemic secondary to a novel coronavirus - SARS-CoV-2. The reported case-fatality ratio for SARS-CoV-2 in the United States is 1.8% with ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04896606
Start Date
September 20 2021
End Date
December 31 2025
Last Update
October 26 2023
Active Locations (4)
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1
New York Medical College
Valhalla, New York, United States, 10595
2
Nationwide Children's Hosptial
Columbus, Ohio, United States, 43205
3
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Medical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226