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Virus Therapy

Genetically Modified T-cells for Infections in Cancer Patients

Phase 1

Recruiting

Led By May Daher, MD

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

For BKV infection, patients need to have polymerase chain reaction (PCR) positive for BKV (in peripheral blood or urine) with consistent clinical symptoms

For COVID-19 infection, patients need to have COVID-19 related pneumonia/acute respiratory distress syndrome (ARDS) to be enrolled, defined as patients with a positive COVID-19 test (bronchoalveolar lavage [BAL], nasal or pharyngeal) and radiological and clinical signs of pneumonia or ARDS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is testing the feasibility and safety of genetically modified T-cells to control viral infections in immunocompromised cancer patients. If successful, this could provide a new, less toxic option for treating these life-threatening infections.

Who is the study for?

This trial is for adults with blood cancers and certain viral infections (ADV, BKV, CMV, JCV, COVID-19) after stem cell transplant or with pneumonia from COVID-19. They must be able to consent and agree to long-term follow-up. Women who can have children should use two birth control methods during the study.Check my eligibility

What is being tested?

The trial tests genetically engineered virus-specific T-cells designed to fight specific viruses causing infections in cancer patients with weakened immune systems. It aims to see if these modified cells are safe and effective at controlling the infection.See study design

What are the potential side effects?

Potential side effects may include immune reactions as the body adjusts to the new T-cells, symptoms related to inflammation or damage of infected tissues as viruses are targeted, and typical risks associated with cellular therapies.

Eligibility Criteria

Inclusion Criteria

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

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I have symptoms and tested positive for BKV in my blood or urine.

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I have COVID-19 and am suffering from pneumonia or ARDS.

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I have been diagnosed with JC virus infection affecting my brain or other organs.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Feasibility of administering genetically engineered glucocorticoid receptor knock out virus specific cytotoxic T-lymphocyte (CTL) lines, as indicated by Overall Survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment for viral infections (virus-specific CTLs)Experimental Treatment1 Intervention

Patients receive virus-specific CTLs intravenously (IV) over 30 minutes. Patients with partial response, stable disease, or progressive disease may receive up to 8 additional infusions of virus-specific CTL at least 2 weeks between each infusion.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,316 Total Patients Enrolled

2 Trials studying Adenovirus Infections

60 Patients Enrolled for Adenovirus Infections

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,824 Total Patients Enrolled

May Daher, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Adenovirus Infections Research Study Groups: Treatment for viral infections (virus-specific CTLs)

Frequently Asked Questions

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

Are there any vacancies available within this clinical trial?

"Clinicaltrials.gov states that this medical trial is not currently open for enrollment, although it was initially announced on January 1st 2023 and its details were last updated in October 25th 2022. Fortunately, there are 4206 other clinical trials actively recruiting participants at the moment."

Answered by AI

Has the FDA sanctioned Virus-specific Cytotoxic T-lymphocytes as a viable treatment option?

"Given the limited data around efficacy and safety, Virus-specific Cytotoxic T-lymphocytes scored a 1 on our team at Power's scale of risk assessment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients

2023. "Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05101213.

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