SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04896606|
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : March 27, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Covid19||Other: Standard of Care Biological: SARS-CoV2-CTLS||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|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)|
|Actual Study Start Date :||September 20, 2021|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2025|
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.
Other: Standard of Care
Patients will receive standard of care for COVID-19.
Patients may receive up to 5 CTL infusions to treat SARA-CoV-2 in combination with standard of care.
Active Comparator: Standard of Care Only
Patients will NOT received COVID CTLs but will get standard of care.
Other: Standard of Care
Patients will receive standard of care for COVID-19.
- Incidence of adverse events [ Time Frame: 12 weeks ]no adverse events will occur due to CTL infusion(s)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896606
|Contact: Mitchell S Cairo, MDemail@example.com|
|Contact: Lauren Harrison, RN, MSNfirstname.lastname@example.org|
|United States, New York|
|New York Medical College||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Lauren Harrison, MSN, RN 617-285-7844 email@example.com|
|Contact: Elizabeth Mintzer firstname.lastname@example.org|
|United States, Ohio|
|Nationwide Children's Hosptial||Not yet recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Dean Lee, MD, PhD 614-722-3550 Dean.Lee@nationwidechildrens.org|
|United States, Pennsylvania|
|Children's Hospital of Pennsylvania||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Nancy Bunin, MD 215-590-2255 email@example.com|
|United States, Wisconsin|
|Medical College of Wisconsin/Children's Hospital of Wisconsin||Not yet recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Julie A Talano, MD 414-955-4185 firstname.lastname@example.org|
|Contact: Kathy Jodarski 414-266-2681 email@example.com|
|Study Chair:||Mitchell S Cairo, MD||New York Medical College|
|Responsible Party:||New York Medical College|
|Other Study ID Numbers:||
|First Posted:||May 21, 2021 Key Record Dates|
|Last Update Posted:||March 27, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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