Using donor-derived T cells to treat mild to moderate COVID-19

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of SARS-CoV-2 specific cytotoxic T lymphocytes (CTLs) derived from family donors who have recovered from COVID-19 to treat family members with mild to moderate disease. Participants must be hospitalized and have a confirmed SARS-CoV-2 infection, with specific eligibility criteria including age and underlying health conditions. The study aims to assess the safety and effectiveness of these CTLs as a potential treatment option for COVID-19, where no standard therapies currently exist.

Why it matters

Who can join: the full rules

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.

Where it's running

• New York Medical College
  Valhalla, New York, United States Recruiting
• Nationwide Children's Hosptial
  Columbus, Ohio, United States Not yet recruiting
• Children's Hospital of Pennsylvania
  Philadelphia, Pennsylvania, United States Not yet recruiting
• Medical College of Wisconsin/Children's Hospital of Wisconsin
  Milwaukee, Wisconsin, United States Not yet recruiting

Study contacts

• Study coordinator: Mitchell S Cairo, MD
• Email: mitchell_cairo@nymc.edu
• Phone: 9145942150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.