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T-cell Therapy

Donor T Cell Therapy for Adenovirus Infections

Phase 1

Recruiting

Led By David Marin

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing the side effects of a new treatment for patients with a weakened immune system and adenovirus-related disease. The treatment is made from donated blood cells and is designed to kill viruses that can cause infections.

Who is the study for?

This trial is for immunocompromised patients with blood cancers and asymptomatic adenovirus viremia, or those showing probable or definitive signs of the disease. Participants must consent, not be pregnant, agree to use contraception if applicable, and cannot have certain uncontrolled infections or recent treatments that suppress the immune system.Check my eligibility

What is being tested?

The study tests donor T cell therapy using allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) in patients with weakened immune systems due to blood cancers. These CTLs are grown from donated cells aimed at fighting off adenovirus infections.See study design

What are the potential side effects?

Potential side effects may include reactions related to the infusion of foreign cells such as fever, chills, fatigue, headache, muscle aches; there's also a risk of these cells attacking healthy body tissues (graft-versus-host disease).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

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

Assessment of response to allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs)

Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0

Secondary outcome measures

Cumulative incidence of adenovirus reactivation after therapy

Cumulative incidence of graft versus host disease (GVHD)

Overall survival (OS)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (allogeneic adenovirus-specific CTLs)Experimental Treatment1 Intervention

Within two weeks of enrollment, patients receive allogeneic adenovirus-specific CTLs IV over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,989 Total Patients Enrolled

1 Trials studying Blood Cancers

70 Patients Enrolled for Blood Cancers

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,305 Total Patients Enrolled

David MarinPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Donor T Cell Therapy (T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03425526 — Phase 1

Blood Cancers Research Study Groups: Treatment (allogeneic adenovirus-specific CTLs)

Blood Cancers Clinical Trial 2023: Donor T Cell Therapy Highlights & Side Effects. Trial Name: NCT03425526 — Phase 1

Donor T Cell Therapy (T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03425526 — Phase 1

Frequently Asked Questions

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

How many individuals have been recruited for this experiment?

"Indeed, clinicaltrials.gov reveals that recruitment for this trial is still in progress. This research project was posted on March 15th 2018 and last updated on September 7th 2022; 16 participants are needed from a single medical facility."

Answered by AI

Are new participants being invited to join this research endeavor?

"Affirmative. Clinicaltrials.gov has the latest information that this clinical trial is presently recruiting individuals. The study was first uploaded on March 15th 2018, with its most recent update occuring on September 7th 2022; it targets 16 subjects between 1 centre of research."

Answered by AI

Has the FDA conferred authorization on Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes?

"Despite being a Phase 1 trial, signifying limited research into its safety and efficacy, we at Power rate Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes as having comparatively high levels of security with a score of 1."

Answered by AI

What are the primary goals to be achieved by this medical experiment?

"This clinical research spans up to a year and evaluates the efficacy of allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs). Secondary objectives include monitoring cumulative incidences of graft versus host disease (GVHD), relapse-free survival, and reactivation of the virus. Patients who survive without any progression at the conclusion will be censored in order to accurately measure these outcomes using Kaplan Meier and competing risks methods respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease

2018. "Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03425526.

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