ClinicalTrials.gov

History of Changes for Study: NCT04765449
Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection
Latest version (submitted August 15, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 February 19, 2021 None (earliest Version on record)
2 February 25, 2021 Study Design, Study Status and Study Identification
3 March 4, 2021 Study Status
4 April 14, 2021 Study Status and Eligibility
5 June 3, 2021 Study Status
6 July 6, 2021 Study Status, Arms and Interventions, Eligibility, Study Description, Contacts/Locations, Outcome Measures and Study Identification
7 July 19, 2021 Outcome Measures and Study Status
8 August 31, 2021 Study Status
9 September 21, 2021 Recruitment Status, Study Status and Contacts/Locations
10 December 6, 2021 Study Status and Eligibility
11 December 15, 2021 Eligibility and Study Status
12 January 26, 2022 Study Status and Eligibility
13 June 13, 2022 Study Status and Arms and Interventions
14 August 15, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT04765449
Submitted Date:  February 19, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20P.015
Brief Title: Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection
Official Title: Third-Party Covid-19-Specific Cytotoxic T Lymphocytes for the Treatment of Elderly and High-Risk Patients With Covid-19 Infection
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2021
Overall Status: Not yet recruiting
Study Start: March 30, 2021
Primary Completion: August 31, 2023 [Anticipated]
Study Completion: February 29, 2024 [Anticipated]
First Submitted: February 19, 2021
First Submitted that
Met QC Criteria:
February 19, 2021
First Posted: February 21, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
February 19, 2021
Last Update Posted: February 21, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Thomas Jefferson University
Responsible Party: Sponsor
Collaborators: Tevogen Bio Inc
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Covid19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 24 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm A: Covid-19 Patients Receiving CTLs Drug: Cytotoxic T Lymphocytes
Given IV
Other Names:
  • CTLs
No Intervention: Arm B: Covid-19 Patients Not Receiving CTLs
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. 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.
3. 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
4. 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
5. 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
6. 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
Open or close this module Eligibility
Minimum Age: 70 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Dolores Grosso, DNP
Telephone: 215-955-8874
Email: Dolores.Grosso@jefferson.edu
Locations: United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services