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Virus Therapy
Cytotoxic T-Lymphocytes for Adenovirus Infections
Phase 2
Recruiting
Led By Mitchell Cairo, MD
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
grade 2 renal insufficiency secondary to cidofovir
Age: 0.1 to 30.00 years
Must not have
Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of CTL infusion
Known HIV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after last infusion
Awards & highlights
Summary
This trial will test the safety and effectiveness of using related donor ADV specific CTLs to treat patients with refractory ADV infection post AlloHSCT, PID or solid organ transplant.
Who is the study for?
This trial is for children, adolescents, and young adults (0.1-30 years old) with stubborn adenovirus infections after a stem cell or organ transplant, or those with primary immunodeficiencies. They must have tried antiviral treatments without success and be in relatively stable condition. A related donor who matches the patient's tissue type and can respond to the virus is also needed.
What is being tested?
The study tests if special immune cells called cytotoxic T-lymphocytes from a related donor can fight off tough adenovirus infections when standard antiviral drugs fail. These cells are given through an IV and are designed to target the virus directly.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, symptoms similar to flu-like illnesses due to immune response activation, allergic reactions including hypersensitivity, and possibly other unforeseen complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is reduced due to cidofovir treatment.
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I am between 1 month and 30 years old.
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I need a new donor because my original one can't help. The new donor matches me and responds to a specific test.
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I can do most activities by myself.
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I have an Adenovirus infection after a transplant or with a primary immune deficiency.
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My donor has completed all required health screenings.
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I have a related donor with a specific immune response to a virus.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am HIV positive.
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I am not pregnant, breastfeeding, and I agree to use birth control during the study.
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I am mostly bedridden and unable to care for myself.
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I received a donor lymphocyte infusion less than 4 weeks ago.
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I am taking steroids equivalent to more than 0.5 mg/kg of prednisone at the time of my cell therapy infusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks after each infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after each infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Response to Treatment (Efficacy)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Trial Design
1Treatment groups
Experimental Treatment
Group I: patients with adenoviral infectionExperimental Treatment1 Intervention
patients will receive CTL dose x 1 with 2.5 × 10(4) CD3/kg for matched related donor and 0.5 × 104 CD3/kg for mis-matched related donor. Patients who don't respond to the first infusion may receive up to a total 5 CTL infusions.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineOTHER
1,970 Previous Clinical Trials
2,308,603 Total Patients Enrolled
University of California, Los AngelesOTHER
1,554 Previous Clinical Trials
10,264,094 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
721 Previous Clinical Trials
8,604,307 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.You have experienced negative reactions or side effects from antiviral treatments in the past.My kidney function is reduced due to cidofovir treatment.I am between 1 month and 30 years old.I am a woman who can have children and my pregnancy test is negative.I have symptoms or test results showing adenovirus infection despite 2 weeks of treatment.I can do most activities by myself.I am not pregnant, breastfeeding, and I agree to use birth control during the study.I need a new donor because my original one can't help. The new donor matches me and responds to a specific test.I have an Adenovirus infection after a transplant or with a primary immune deficiency.My donor has completed all required health screenings.You are allergic to iron dextran.I am mostly bedridden and unable to care for myself.I have a related donor with a specific immune response to a virus.I received a donor lymphocyte infusion less than 4 weeks ago.I am taking steroids equivalent to more than 0.5 mg/kg of prednisone at the time of my cell therapy infusion.
Research Study Groups:
This trial has the following groups:- Group 1: patients with adenoviral infection
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.
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