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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Cumulative incidence of adenovirus reactivation after therapy
Cumulative incidence of graft versus host disease (GVHD)
Overall survival (OS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,044 Total Patients Enrolled
2 Trials studying Blood Cancers
112 Patients Enrolled for Blood Cancers
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,593 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
~4 spots leftby Jan 2027
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