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CAR T-cell Therapy

T-lymphocyte Therapy for Adenovirus Infections (ADV-VSTS Trial)

Phase 1 & 2

Recruiting

Led By Eunkyung Song, MD

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of refractory ADV end organ disease (proven or probable as previously defined46, including pneumonitis, colitis, hepatitis, hemorrhagic cystitis etc.) despite antiviral therapy >14 days.

Medical intolerance to anti-viral therapies including renal toxicity (Cr >2) and/or bone marrow suppression (ANC <1500, Hb <10 and/or Plt <50) or gastrointestinal manifestation (grade ≥2 diarrhea), or other related organ injury.

Must not have

Receiving corticosteroid (prednisone equivalent) ≥ 0.5mg/kg/day or ≥ 20mg/day at the time of enrollment

Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7-28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the safety and efficacy of adenovirus-specific T lymphocytes isolated from blood or leukapheresis products, generated by the CliniMACS Prodigy.

Who is the study for?

This trial is for people with stubborn adenovirus infections who can't tolerate antiviral drugs due to kidney or bone marrow issues, or have had organ transplants. It's open to ages 0-60 and includes those on recent chemotherapy or immunosuppressants. Pregnant women and those with uncontrolled infections, HIV, or certain drug treatments are excluded.

What is being tested?

The study tests adenovirus-specific T lymphocytes from related donors to see if they're safe and effective against tough-to-treat adenovirus infections. These special immune cells are prepared using a system that selects them based on their response to specific viral parts.

What are the potential side effects?

Potential side effects aren't detailed here but could include reactions related to the immune system's response to the infused T-cells, such as fever, fatigue, headache, muscle pain, and possible worsening of infection symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an organ disease not responding to antiviral treatment for over 14 days.

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I cannot tolerate anti-viral medications due to kidney issues, low blood counts, severe diarrhea, or other organ damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking a high dose of steroids.

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I am on a final treatment for a bacterial infection and have shown no worsening signs for 3 days.

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I am not pregnant, breastfeeding, and I agree to use birth control during the study.

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My health severely limits my daily activities.

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I am HIV positive.

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I have received a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7-28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy by measuring viral load

Safety by measuring unacceptable toxicities

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RecipientExperimental Treatment1 Intervention

Recipient will undergo a screening period that will include history and physical examination, laboratory tests, performance status, HLA typing and pregnancy test (if needed). Qualified patients will receive ADV-VSTS infusion from haploidentical donors up to a maximum of 5.0 x 104 interferon gamma-negative cells/kg. All patients will be followed for laboratory and clinical response, safety, efficacy and tolerance.

Group II: DonorActive Control1 Intervention

Donors will be evaluated to determine suitability to undergo apheresis collection and their infectious disease status. Donor evaluation will include history and physical examination, laboratory tests, FDA- approved donor testing of communicable diseases (HIV, HVB, HCV, HTLV-I, II, WNV, T. pallidum, T. cruzi, and Zika virus), ABO and Rh typing, pregnancy tests, and donor serology for ADV. Qualified donors will undergo leukapheresis. Collection will proceed for 2 hours or 2 blood volumes, whichever occurs first.

0 / 8Eligibility criteria met