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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after infusion

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with severe adverse events

Secondary outcome measures

Number of patients with clinical response

Number of patients with viral response

Time from enrollment to T cell product infusion

+1 more

Side effects data

From 2023 Phase 2 trial • 28 Patients • NCT03063632

31%

Fatigue

31%

Skin and subcutaneous tissue disorders - Other

25%

Diarrhea

25%

Rash maculo-papular

25%

Headache

19%

Surgical and medical procedures - Other

19%

Hypokalemia

13%

Myalgia

13%

Depression

13%

Skin infection

13%

Edema limbs

13%

Fever

13%

Flu like symptoms

13%

Insomnia

13%

Nausea

13%

Infections and Infestations, Other

13%

Investigations - Other

13%

Urinary tract Infection

13%

Cough

13%

Dehydration

Acute kidney injury

Malaise

Anemia

Hyponatremia

Abdominal pain

Vomiting

Alanine aminotransferase increased

Atrial fibrillation

Disease progression

Alkaline phosphatase increased

Arthralgia

Skin papilloma

Tooth infection

Anxiety

Arthritis

Aspartate aminotransferase increased

Bladder infection

Blood and lymphatic system disorders - Other, specify

Edema face

Erythroderma

Flushing

Gait disturbance

Gastrointestinal disorders - Other, specify

General disorders and administration site conditions - Other, specify

Platelet count decreased

Productive cough

Pruritus

Syncope

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other

Respiratory, thoracic and mediastinal disorders - Other

Toothache

Upper respiratory infection

Dizziness

Dyspepsia

Fracture

Hematuria

Soft tissue infection

Keratitis

Nervous system disorders - Other

Skin hypopigmentation

Hypercalcemia

Blood bilirubin increased

Bone infection

Anorexia

Blood lactate dehydrogenase increased

Concentration impairment

Creatinine increased

Dry skin

Hypoglycemia

Urinary incontinence

Weight loss

White blood cell count decreased

100%

80%

60%

40%

20%

Study treatment Arm

Group I (Pembrolizumab, Interferon Gamma-1b)

Group II (Pembrolizumab, Interferon Gamma-1b)

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 / 3Eligibility criteria met