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Virus Therapy

Viral Specific T Cell Therapy for COVID-19

Q: What is the cohort size associated with this research endeavor?

<p>Correct. Data hosted on clinicaltrials.gov suggests that this medical trial, which was first posted on December 18th 2020, is currently recruiting patients. The research team needs to enroll 16 individuals from a single clinic location.</p>

Q: Is enrollment still being accepted for this research study?

<p>According to clinicaltrials.gov, this trial is still recruiting patients as of July 13th 2022 - the date it was last updated since its initial posting on December 18th 2020.</p>

Phase < 1

Waitlist Available

Led By Katy Rezvani

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients with hematological malignancies who have been in MRD-negative CR for more than 3 years and have a peripheral blood CD4 count < 200 x 10^9cells/liter

Recipients of a stem cell transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months post-infusion

Awards & highlights

Study Summary

This trial is testing if SARS-CoV-2 specific cytotoxic T lymphocytes (CTLs), a type of immune cell, can help control the COVID-19 in cancer patients.

Who is the study for?

This trial is for cancer patients with weakened immune systems due to treatments or low CD4 counts, who have COVID-19. They must be in remission or not planning further cancer treatment soon and able to follow the study rules. Pregnant women can't join, and participants need a negative pregnancy test and agree to use contraception.Check my eligibility

What is being tested?

The trial tests if special immune cells (CTLs) grown from donated blood can fight COVID-19 in these patients. It's an early-stage study looking at whether this approach is doable, beneficial, and what side effects it might have.See study design

What are the potential side effects?

Possible side effects are not detailed but may include typical reactions related to immune cell transfusions such as fever, chills, fatigue, headache, muscle pain, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've been cancer-free for over 3 years but have a low CD4 count.

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I have received a stem cell transplant.

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I am 18 or older, tested positive for COVID-19 recently, and have respiratory symptoms.

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My immune system is weakened due to my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months post-infusion

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

Treatment Details

Study Objectives

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

Primary outcome measures

Assessment of feasibility

Incidence of adverse events

Secondary outcome measures

All-cause mortality

Cumulative incidence of coronavirus disease 2019 pneumonia resolution after therapy

Cumulative incidence of grade 2-4 or 3-4 graft versus host disease (GVHD), and chronic GVHD

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SARS-COV-2 specific cytotoxic T cells)Experimental Treatment1 Intervention

Patients receive SARS-COV-2 specific cytotoxic T lymphocytes IV over 30 minutes on day 1. Treatment may repeat every 14 days at investigators' discretion if patient fails to respond, the infection reoccurs, until the viral load becomes negative or until complete resolution of clinical and radiological signs.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,770 Total Patients Enrolled

14 Trials studying COVID-19 Infection

74,955 Patients Enrolled for COVID-19 Infection

Katy RezvaniPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

100 Total Patients Enrolled

David Marin, MDPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

94 Total Patients Enrolled

Media Library

SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04742595 — Phase < 1

COVID-19 Infection Research Study Groups: Treatment (SARS-COV-2 specific cytotoxic T cells)

COVID-19 Infection Clinical Trial 2023: SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes Highlights & Side Effects. Trial Name: NCT04742595 — Phase < 1

SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04742595 — Phase < 1

Frequently Asked Questions

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

What is the cohort size associated with this research endeavor?

"Correct. Data hosted on clinicaltrials.gov suggests that this medical trial, which was first posted on December 18th 2020, is currently recruiting patients. The research team needs to enroll 16 individuals from a single clinic location."

Answered by AI

Is enrollment still being accepted for this research study?

"According to clinicaltrials.gov, this trial is still recruiting patients as of July 13th 2022 - the date it was last updated since its initial posting on December 18th 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Viral Specific T Cell Therapy for COVID-19 Related Pneumonia

2020. "Viral Specific T Cell Therapy for COVID-19 Related Pneumonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04742595.