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CAR T-cell Therapy

Adoptive Immunotherapy for Viral Infections

Phase 1 & 2

Recruiting

Research Sponsored by Catherine Bollard

Eligibility Criteria Checklist

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

Must have

Lansky/Karnofsky scores ≥60

Recipients of at least one unmanipulated cord blood unit transplant at risk for or with specific infections

Must not have

Patient on Fi02 of >60%

Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is a Phase I-II dose-finding trial to determine the optimal dose of intravenous injection of donor-derived cytotoxic T lymphocytes specific for CMV, EBV, BKV, and Adenovirus.

Who is the study for?

This trial is for pediatric and adult patients with malignant or nonmalignant diseases who are candidates for a cord blood transplant. They must have a certain level of physical function, no severe organ damage, and be at least 30 days post-transplant without significant graft-versus-host disease. It's not for pregnant women, those with very low performance status, uncontrolled infections other than the viruses in question, or those who've received another investigational product within 28 days.

What is being tested?

The trial tests different doses of donor-derived T cells that fight CMV, EBV, BKV and Adenovirus in patients receiving cord blood transplants. Up to 36 patients will receive one of three escalating dose levels determined by an adaptive method to find the optimal balance between effectiveness and toxicity.

What are the potential side effects?

Potential side effects may include immune reactions where the body attacks its own tissues (GVHD), infusion-related reactions like fever or chills during T cell administration, increased risk of infection due to immune system suppression from treatment.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may need occasional help.

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I received a cord blood transplant and am at risk for certain infections.

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My liver is functioning well.

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I do not have severe graft-versus-host disease.

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My cord blood unit matches me on 4-6 key immune system markers.

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My kidneys are functioning well.

Exclusion Criteria

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

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I am on high levels of oxygen therapy.

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My transplant is not fully matching or my original disease has returned.

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I cannot reduce my steroid dose to less than or equal to 0.5 mg/kg/day.

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I have severe jaundice.

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I need assistance with my daily activities.

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I have a severe form of primary myelofibrosis.

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I have an active brain or spinal cord disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with investigational product-related adverse events as assessed by CTCAE v4.03

Secondary study objectives

Impact of CMV/AdV /EBV/BKV specific T cells will be measured by existence of cells in the system.

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: CMV/AdV /EBV/BKV specific T cellsExperimental Treatment1 Intervention

CMV/AdV /EBV/BKV specific T cells will be thawed and transferred to a syringe given by slow intravenous injection over 1-2 minutes. Three dose levels will be explored. The lowest dose level will be 1x107cells/m2 and the highest will be 5x107/m2.

0 / 13Eligibility criteria met