Recruiting

Phase 1

Phase 2

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

Sponsor:

New York Medical College

Code:

NCT04896606

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Standard of Care

SARS-CoV2-CTLS

Study Details

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 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.

Conditions

Covid19

Study ID

NCT04896606

Start date

Sep 20, 2021

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SARS-CoV-2 CTLS + Standard of Care

Patients will get family donor derived SARS-CoV-2 cytotoxic t-lymphocytes up to 5 times every 2 weeks along with Standard of care of COVID-19.

active comparator: Standard of Care Only

Patients will NOT received COVID CTLs but will get standard of care.

Interventions

Standard of Care

Patients will receive standard of care for COVID-19.

SARS-CoV2-CTLS

Patients may receive up to 5 CTL infusions to treat SARA-CoV-2 in combination with standard of care.

Primary outcome measure

Incidence of adverse events [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Mitchell S Cairo, MD

9145942150 mitchell_cairo@nymc.edu

Lauren Harrison, RN, MSN

16172857844 lauren_harrison@nymc.edu

Locations

New York Medical College

Recruiting

Valhalla, New York, United States, 10595

Contacts

Lauren Harrison, MSN, RN

617-285-7844 lauren_harrison@nymc.edu

Elizabeth Mintzer

emintzer2@nymc.edu

More Information

Sponsor

New York Medical College

Last update posted

Apr 13, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Medical College on 2026-04-13.