Clinical Trials

Third-Party Covid-19-Specific Cytotoxic T Lymphocytes for the Treatment of Elderly and High-Risk Patients with Covid-19

An Open-label single center two arm study to assess the safety and efficacy of COVID-19-specific T cells when given as treatment to adult patients (age ≥ 18 years) with a newly diagnosed COVID-19 infection. This immunologic treatment is aimed at patients, who are at high risk of progression due to their advanced age, or other underlying health conditions.

Last Update: Sep 23, 2021

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Inclusion Criteria

Have a newly diagnosed documented active COVID-19 infection and one of the following high-risk criteria:

• Malignancy receiving radiation or chemotherapy in the prior 12 months.
• Lack of response to COVID-19 vaccination based on antibody testing (N.B. a positive response to COVID-19 vaccination does not eliminate a candidate from eligibility if one of the other criteria are met)
• Chronic lung disease such as asthma, COPD, interstitial lung disease, pulmonary hypertension or cystic fibrosis, requiring treatment beyond inhaled medications
• Hypertension either treated or with evidence of need for treatment
• Cardiovascular disease requiring active medical monitoring and care including heart failure, heart dysrhythmias, coronary artery disease, congenital heart disease, cardiomyopathy, or pulmonary hypertension
• History of ischemic stroke
• Diabetes (type 1, type 2, or gestational) requiring treatment with insulin or oral hypoglycemics
• Chronic Kidney Disease (Hx of stage 3b or greater as defined by the National Kidney Foundation)
• Chronic Liver Disease (Previously diagnosed with cirrhosis or previously classified as having Pugh-Child class A-C liver disease)
• Obesity (BMI >= 30 or greater) (https://www.cdc.gov/media/releases/2020/p0625-update-expands-covid-19.html)
• Sickle Cell Disease or Thalassemia
• Patients requiring nursing home support or who have a Karnofsky Performance Status of 70% or less antedating their COVID-19 illness.
• Age >= 65 (with or without previously identified comorbid conditions)
• The following must also be met:
  • Premenopausal women (age <50 years) must demonstrate a negative pregnancy test
  • Patient or guardian or family member ability to give informed consent
  • To be included in the treatment group, a patient must also express the HLA A*02:01 allele in common with the stored CTL product.

Exclusion Criteria

• Matching their intended CTL product donor at 5 or 6 of 6 HLA-class I (HLA-A, B, and C) alleles.
• Requiring supplemental oxygen
• Evidence of active COVID-19-related CRS as evidenced by 2 or more of the following characteristics of cytokine storm:
  • >grade 1 CRS on ASTCT criteria. ASTCT criteria do not provide quantitative guidelines regarding the definition of hypotension. For this trial, hypotension will be defined as:
    1. requiring vasopressors
    2. Systolic blood pressure <110 mm Hg
    3. Diastolic B/P < 70 mm Hg NB Lower systolic and diastolic blood pressures will be acceptable if patient’s blood pressure is at his/her known baseline.
  • Uncontrolled hypertension as defined by a systolic pressure of > 160 mm Hg or diastolic pressure > 95 mm Hg. A second blood pressure reading may be obtained by study personnel to assure blood pressure accuracy.
  • Radiographic studies consistent with adult respiratory distress syndrome
  • Requiring acute dialysis hyperferritinemia as defined by ferritin > 2000 ng/mL 55
  • Concurrent treatment with >5 mg of prednisone daily (or equivalent).
• Current or ongoing administration of calcineurin inhibitors, chemotherapy, radiation, or other immunosuppressive agents.
• Receipt of agents with ongoing immunosuppressive properties in the last 30 days including, ATG, Alemtuzumab, or similar agents.
• Prior bone marrow, stem cell, or solid organ transplant
• Active HIV infection with CD4 count less than 200/ul.
• Known autoimmune disease requiring systemic treatment.
• Pregnancy (lactating females allowable)
• Concomitant treatment with another experimental intervention for COVID-19 other than Remdesivir.
• History of allergic reaction to cellular therapy products (includes blood transfusion), diphenhydramine, or tocilizumb
• Corrected QT interval > 450 milliseconds
• History of torsade de pointes or other ventricular arrhythmia Women of childbearing potential, and partners of women of childbearing potential should be using at least one method of highly effective contraception at the time of enrollment and for the 14-day duration of the study.

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Study Description

This is a single arm, two arm study in up to 24 participants with a newly diagnosed active COVID-19 infection. The COVID-19 specific T cells have to have an immune protein called HLA in common with a patient to work. If a patient enrolled on the COVID-19 study has this HLA, they will receive a dose of the COVID-19 T cells. Patients will receive the T cells intravenously in the hospital and be monitored there for 4 days before being discharged. After discharge, study staff will continue to monitor patient symptoms and recordings with video visits or phone calls daily until the monitoring period of 14 days is over. Patients will also be asked to give blood samples 7, 14, 28, days and 2, 3, and 6 months after the T cells are given. Patients who meet study criteria and wish to participate but do not have the HLA protein in common with the T cells, will be monitored by study personnel in their own homes for the full 14 day period. These patients may be treated with any standard or experimental COVID-19 therapy. How patients handle their COVID-19 infection will be compared between the group of people receiving the T cells and the group of people who do not receive the T cells.

ClinicalTrials.gov Identifier NCT04765449
For more information, please visit clinicaltrials.gov.

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Study Location

Recruiting
Thomas Jefferson University Hospitals
901 Walnut St, Philadelphia PA 19107

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