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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

No Placebo-Only Group

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after each infusion for reporting.

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]

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: 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.

0 / 13Eligibility criteria met