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

Overview

The purpsse of this research is to assess the safety and effectiveness of a new experimental treatment for COVID-19 infection. While the infection and virus actually have different names, for the purpose of this consent, we will refer to them both as COVID-19. Specifically, this is the virus that has caused the pandemic that moved across the world in early 2020. You are being offered this experimental treatment because you have tested positive for the COVID-19 virus and have additional reasons to be considered at higher risk for a more serious outcome compared to the average patient who develops this infection.

Full Title of Study: “Third-Party Covid-19-Specific Cytotoxic T Lymphocytes for the Treatment of Elderly and High-Risk Patients With Covid-19 Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2023

Interventions

  • Drug: Cytotoxic T Lymphocytes
    • Given IV

Arms, Groups and Cohorts

  • Experimental: Arm A: Covid-19 Patients Receiving CTLs
  • No Intervention: Arm B: Covid-19 Patients Not Receiving CTLs

Clinical Trial Outcome Measures

Primary Measures

  • Safety of COVID-19-specific CTLs: Infusion Reactions
    • Time Frame: Within 48 Hours of CTL Infusion
    • Safety will be measured by the absence of: Grade ≥ 3 acute infusion reactions
  • Safety of COVID-19-specific CTLs: Grade 4 AEs
    • Time Frame: Within 14 days of CTL infusion
    • Safety will be measured by the absence of: Any grade 4 or higher adverse event thought to be related to the CTL therapy and outside the spectrum of identified COVID related events.
  • Safety of COVID-19-specific CTLs: GVHD
    • Time Frame: Within 14 days of CTL infusion
    • Safety will be measured by the absence of: Any manifestation of acute GVHD (for acute grades 2-4 GVHD-Glucksberg criteria) 53 resistant to 2 mg/kg of solumedrol or equivalent
  • Safety of COVID-19-specific CTLs: Marrow Aplasia
    • Time Frame: Within 14 days of CTL infusion
    • Safety will be measured by the absence of: Marrow aplasia due to 3rd party engraftment
  • Safety of COVID-19-specific CTLs: Neurotoxicty
    • Time Frame: Within 14 days of CTL infusion
    • Safety will be measured by the absence of: Grade ≥ 2+ Neurotoxicity as measured by the ASTCT/ICANS consensus grading system
  • Safety of COVID-19-specific CTLs: CRS
    • Time Frame: Within 14 days of CTL infusion
    • Safety will be measured by the absence of: Grade ≥ 2+ CRS as measured by the ASTCT Consensus Grading Criteria for CRS

Participating in This Clinical Trial

Inclusion Criteria

•Have a documented active COVID-19 infection and one of the following high-risk criteria: oAge >= 70 (with or without previously identified comorbid conditions) AND/OR any one of the following comorbid conditions: oMalignancy receiving radiation or chemotherapy in the prior 12 months oChronic lung disease such as asthma, COPD, interstitial lung disease, pulmonary hypertension or cystic fibrosis, requiring treatment beyond inhaled medications oHypertension either treated or with evidence of need for treatment oCardiovascular disease requiring active medical monitoring and care including heart failure, heart dysrhythmias, coronary artery disease, congenital heart disease, cardiomyopathy, or pulmonary hypertension oHistory of ischemic stroke oDiabetes (type 1, type 2, or gestational) requiring treatment with insulin or oral hypoglycemics oChronic Kidney Disease (Hx of stage 3b or greater as defined by the National Kidney Foundation) oChronic 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 oPatients requiring nursing home support or who have a Karnofsky Performance Status of 70% or less antedating their COVID-19 illness.

  • 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 at least 1 HLA allele in common with a 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: 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.

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Thomas Jefferson University
  • Collaborator
    • Tevogen Bio Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Dolores Grosso, DNP, 215-955-8874, Dolores.Grosso@jefferson.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.