RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 a current death toll of \>300,000 and climbing.4 There is no accepted standard of care or FDA approved therapies for treatment of COVID-19. Virus specific cytotoxic T lymphocytes (CTLs) have become an important part of the treatment landscape for viral reactivation post hematopoietic and solid organ transplantation. Donor derived CTLs have been shown to be safe and effective against a variety of viruses including CMV, EBV, BK and adenovirus. We hypothesize that SARS-CoV-2 specific CTLs generated from a previously infected family donor will be safe and effective for treatment of COVID-19 in family members with mild to moderate disease.

Official Title

A Pilot Study of SARS-CoV-2 Specific Cytotoxic T Lymphocytes (SARS-CoV-2-CTLs) for Treatment of Mild to Moderate Coronavirus Disease 2019 (COVID-19)

Quick Facts

Study Start:2021-09-20

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04896606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Study Contact

Mitchell S Cairo, MD

CONTACT

9145942150

mitchell_cairo@nymc.edu

Lauren Harrison, RN, MSN

CONTACT

16172857844

lauren_harrison@nymc.edu

Principal Investigator

Mitchell S Cairo, MD

STUDY_CHAIR

New York Medical College

Study Locations (Sites)

New York Medical College

Valhalla, New York, 10595

United States

Nationwide Children's Hosptial

Columbus, Ohio, 43205

United States

Children's Hospital of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Medical College of Wisconsin/Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: New York Medical College

Mitchell S Cairo, MD, STUDY_CHAIR, New York Medical College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-20

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-09-20

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Covid19