← Back to Search

CAR T-cell Therapy

Cytotoxic T Lymphocytes for Coronavirus

Q: What evidence is the research team hoping to obtain through this investigation?

<p>This clinical trial is focusing on the safety of <a href="https://www.withpower.com/clinical-trials/covid">COVID</a>-19-specific CTLs, namely GVHD. Over a period of 14 days post infusion, blood and nasal samples will be taken to measure secondary outcomes such as persistence of T cells and viral load. Additionally, endogenous development of specific T cells will also be tracked through sampling.</p>

Phase 1

Waitlist Available

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial will study if it's safe and effective to give T cells to adults with a COVID-19 infection. T cells are a type of immunity cell, and the trial will compare how well patients do when given this treatment to how well they do with the standard of care.

Eligible Conditions

Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of COVID-19-specific CTLs: CRS

Safety of COVID-19-specific CTLs: GVHD

Safety of COVID-19-specific CTLs: Grade 4 AEs

+3 more

Secondary outcome measures

Measurement of COVID-19 viral load

Review of medical history including the need for supplemental oxygen, the ability to return to work, performance status, grade of dyspnea, grade of fatigue, survival, the need for blood pressure support

Studies to detect the persistence of the COVID-19-specific T cells after COVID-19 T cell infusion

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ARM A: Covid-19 Patients Receiving CTLsExperimental Treatment1 Intervention

Patients who have an HLA antigen in common with COVID-19 fighting T cells will receive the COVID-19 T cells. They will be premedicated with diphenhydramine and acetaminophen before the cells are infused intravenously. Close monitoring will continue in the patients' homes for 14 days. Three to six patients will receive a specific dose of T cells, and then if there are no serious side effects, the dose will be increased for the next group of patients. There are 4 doses of T cells to be tested, and each patient will complete a 14 day monitoring period before the next patient can be treated.

Group II: ARM B: Covid-19 Patients Not Receiving CTLsActive Control1 Intervention

Patients in the observation arm will not have inherited an HLA antigen in common with the COVID-19 T cells and so cannot receive the T cells. They will be monitored by the study staff for the 14 day monitoring period in their homes. They will be taught to record their own blood pressure, temperature, and oxygen level (pulse oximetry) at home and report this information, as well as their progress in getting over the COVID-19 infection, to the study staff every day by phone. The outcomes of patients on arm B will be compared to the outcomes of patients treated on Arm A to see if the T cells made a difference in how patients recovered from COVID-19. Patients in Arm B are not prevented from being treated with any available COVID-19 therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytotoxic T Lymphocytes

2012

Completed Phase 1

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,459 Total Patients Enrolled

Tevogen Bio IncUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What evidence is the research team hoping to obtain through this investigation?

"This clinical trial is focusing on the safety of COVID-19-specific CTLs, namely GVHD. Over a period of 14 days post infusion, blood and nasal samples will be taken to measure secondary outcomes such as persistence of T cells and viral load. Additionally, endogenous development of specific T cells will also be tracked through sampling."

Answered by AI

Is this experiment currently admitting new participants?

"This clinical trial, posted on September 15th of 2021 and last updated on the 15th August 2022, is no longer actively recruiting patients. However, there are 1 725 other studies which are currently enrolling volunteers."

Answered by AI

Is the utilization of Cytotoxic T Lymphocytes sanctioned by the FDA?

"Due to the Phase 1 trial status of Cytotoxic T Lymphocytes, there is limited evidence supporting safety and efficacy. Therefore, our team has assigned a score of one for this drug's safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04765449.