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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
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 moreAwards & 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.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,064 Total Patients Enrolled
2 Trials studying Blood Cancers
112 Patients Enrolled for Blood Cancers
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,575 Total Patients Enrolled
David MarinPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and willing to use birth control during the study.I have a virus in my blood but feel fine, confirmed by tests.I have been diagnosed with an adenoviral disease.I am not currently taking high doses of prednisone, nor have I recently received specific immune treatments.I have no worsening infections and am on treatment if I have any.I have a severe reaction from a transplant.I have a blood cancer and my immune system is weak.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (allogeneic adenovirus-specific CTLs)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.