Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection

• Status: Recruiting
• Trial end date: 2022-07-29
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial will study the safety and efficacy of COVID-19-specific T cells when given as treatment to adult patients (age ≥ 18 years) with a 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. The outcomes of patients receiving the T cells (Arm A) will be compared to patients treated with standard of care (Arm B).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborator: Tevogen Bio Inc

Criteria

Inclusion Criteria:

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

• Malignancy receiving radiation or chemotherapy in the prior 12 months.

• 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) oObesity (BMI >= 35) oSickle 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 >= 70 (with or without previously identified comorbid conditions)

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:

o> 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.

oUncontrolled 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.

oradiographic studies consistent with adult respiratory distress syndrome oPatients requiring acute dialysis ohyperferritinemia as defined by ferritin > 2000 ng/mL 55 oConcurrent 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.