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CAR T-cell Therapy

Adoptive T Cell Therapy for Adenovirus Infections After Bone Marrow Transplant

Phase < 1

Recruiting

Led By Mari H Dallas, MD

Research Sponsored by Mari Dallas

Eligibility Criteria Checklist

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

Must have

- Absence of an improvement of viral load (decrease by at least 1 log, i.e. 10-fold) after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir and/or foscarnet. OR

- New, persistent and/or worsening HAdV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet. OR

Must not have

Patients with active, grade II-IV, acute graft versus host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (>0.5 mg/kg/day prednisone or its equivalent) as treatment.

Patients with opportunistic viral infections other than HAdV.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying adoptive T cell therapy to see if it can treat cytomegalovirus (CMV) infection in people with HIV.

Who is the study for?

This trial is for patients who've had a bone marrow transplant at least 30 days ago and are struggling with adenovirus infections despite antiviral treatments, or can't tolerate such treatments. They should have an acceptable performance score indicating they're well enough to participate, be over 14 years old to consent, and use effective contraception.

What is being tested?

The study tests adoptive T cell therapy using donor immune cells (T cells) that fight the adenovirus. These T cells are infused into patients in hopes of boosting their ability to combat the infection. This experimental approach isn't FDA-approved yet.

What are the potential side effects?

Potential side effects include reactions related to infusing foreign cells into the body which could range from mild flu-like symptoms to severe immune responses affecting different organs. The full extent of side effects is still being studied.

Eligibility Criteria

Inclusion Criteria

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

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My viral infection did not improve after 2 weeks of treatment.

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My symptoms or markers of viral infection have gotten worse despite taking antiviral medication.

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I can take care of myself but might not be able to do any work.

Exclusion Criteria

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

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I am currently receiving high doses of steroids for severe graft versus host disease.

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I have a viral infection that is not human adenovirus (HAdV).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after 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

Number of patients with severe adverse events

Secondary study objectives

Number of patients with clinical response

Number of patients with viral response

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: Interferon (IFN)-gamma-secreting HAdV antigen specific T cellsExperimental Treatment1 Intervention

Virus-specific, antigen selected cells will be obtained using the CliniMACS® Prodigy System. The donor will be screened for their ability to produce an IFN-gamma- secretion response to HAdV by testing the donor's mononuclear cells with the Miltenyi Rapid Cytokine Inspector kit. Donors with appropriate IFN-gamma secretion response will undergo a steady state leukapheresis. The investigational product (IP) will be generated using the CCS-IFN enrichment program with an approximate duration time of 15 hours. IP will be suspended in 0.9 normal saline + 2.5% albumin and distributed for infusion and infused within 4 hours as a bolus on day 0. Subjects will receive virus-specific, antigen selected T cells within a targeted range of 1 x 10\^3- 2 x 10\^5 per kg of recipient weight.

0 / 5Eligibility criteria met