Covid19Phase 1/2NCT04896606
SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
A Phase 1/2 study testing SARS-CoV2-CTLS in people with Covid19, run by New York Medical College at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- SARS-CoV2-CTLS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Sep 2021to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Nationwide Children's Hosptial
Columbus, Ohio, 43205
Dean Lee, MD, PhD, (614) 722-3550, Dean.Lee@nationwidechildrens.org
- Not yet recruiting
Medical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Julie A Talano, MD, 414-955-4185, jtalano@mcw.edu
Kathy Jodarski, 414-266-2681, kjodarski@chw.org
- Not yet recruiting
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
Nancy Bunin, MD, 215 590-2255, buninn@email.chop.edu
- Recruiting
New York Medical College
Valhalla, New York, 10595
Lauren Harrison, MSN, RN, 617-285-7844, lauren_harrison@nymc.edu
Elizabeth Mintzer, emintzer2@nymc.edu
About this study
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)
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
- Being tested
- Standard of Care, SARS-CoV2-CTLS
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Patients will receive standard of care for COVID-19.
SARS-CoV2-CTLSBiological
Patients may receive up to 5 CTL infusions to treat SARA-CoV-2 in combination with standard of care.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 CTLS + Standard of Care | Experimental | 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. Receives: Other: Standard of Care; Biological: SARS-CoV2-CTLS |
| Standard of Care Only | Active comparator | Patients will NOT received COVID CTLs but will get standard of care. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
no adverse events will occur due to CTL infusion(s)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start20 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A run-in pilot will be done treating patients with COVID CTLs for safety. If there are no DLTs per definition in the study, study will proceed with a randomized trial of COVID CTLs + standard of care versus just standard of care alone.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Mitchell S Cairo, MD, Study chair, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896606
- Sponsor's protocol ID
- NYMC 604
- Status last verified
- Aug 2025
- First submitted
- 19 May 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chu Y, Milner J, Lamb M, Maryamchik E, Rigot O, Ayello J, Harrison L, Shaw R, Behbehani GK, Mardis ER, Miller K, Prakruthi Rao Venkata L, Chang H, Lee D, Rosenthal E, Kadauke S, Bunin N, Talano JA, Johnson B, Wang Y, Cairo MS. Manufacture and Characterization of Good Manufacturing Practice-Compliant SARS-COV-2 Cytotoxic T Lymphocytes. J Infect Dis. 2023 Mar 28;227(6):788-799. doi: 10.1093/infdis/jiac500.
PubMed 36583990
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04896606
- Acronym / sponsor ID
- NYMC 604
- Conditions
- Covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A run-in pilot will be done treating patients with COVID CTLs for safety. If there are no DLTs per definition in the study, study will proceed with a randomized trial of COVID CTLs + standard of care versus just standard of care alone.
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 CTLS + Standard of Care | Experimental | Other: Standard of Care, Biological: SARS-CoV2-CTLSPatients 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. |
| Standard of Care Only | Active comparator | Other: Standard of CarePatients will NOT received COVID CTLs but will get standard of care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CarePatients will receive standard of care for COVID-19. | Other | SARS-CoV-2 CTLS + Standard of Care, Standard of Care Only |
| SARS-CoV2-CTLSPatients may receive up to 5 CTL infusions to treat SARA-CoV-2 in combination with standard of care. | Biological | SARS-CoV-2 CTLS + Standard of Care |
Primary outcome
Incidence of adverse events
Time frame: 12 weeks
no adverse events will occur due to CTL infusion(s)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 36583990Chu Y, Milner J, Lamb M, Maryamchik E, Rigot O, Ayello J, Harrison L, Shaw R, Behbehani GK, Mardis ER, Miller K, Prakruthi Rao Venkata L, Chang H, Lee D, Rosenthal E, Kadauke S, Bunin N, Talano JA, Johnson B, Wang Y, Cairo MS. Manufacture and Characterization of Good Manufacturing Practice-Compliant SARS-COV-2 Cytotoxic T Lymphocytes. J Infect Dis. 2023 Mar 28;227(6):788-799. doi: 10.1093/infdis/jiac500.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell S Cairo, MD study chair
New York Medical College
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SARS-CoV2-CTLS in people with Covid19, run by New York Medical College at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mitchell S Cairo, MD (9145942150, mitchell_cairo@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04896606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.