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CAR T-cell Therapy

T Cell Therapy for Cytomegalovirus

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

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3

Patients must have documented opportunistic CMV infection, or reactivation; criteria include asymptomatic viremia (>1000 copies/ml) OR presence of symptoms secondary to CMV infection

Must not have

Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid

Patients with opportunistic viral infections other than CMV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 days after transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a T-cell immunotherapy specific to cytomegalovirus (CMV) is a feasible treatment for CMV infections.

Who is the study for?

This trial is for patients who've had a bone marrow transplant and are over 30 days post-transplant, with CMV infections not improving after antiviral therapy or those experiencing side effects from such treatments. Participants need to be able to consent and use contraception if applicable. Excluded are pregnant/breastfeeding women, recent recipients of certain immune therapies, those with other viral infections or active severe graft vs. host disease.

What is being tested?

The study tests the feasibility of using donor-derived T-cells that target cytomegalovirus (CMV) in patients who have received a bone marrow transplant. This cell-based immunotherapy aims to bolster the patient's immune response against CMV infection.

What are the potential side effects?

While specific side effects aren't listed here, adoptive T-cell therapy can potentially cause immune reactions, infusion-related symptoms like fever or chills, and may affect how well the transplanted cells engraft.

Eligibility Criteria

Inclusion Criteria

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

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I am capable of limited self-care and spend more than half of my waking hours out of bed.

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I have a CMV infection shown by tests or symptoms.

Exclusion Criteria

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

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I am currently experiencing severe graft vs. host disease or need high doses of steroids.

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I have a viral infection that is not CMV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 days after transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 days after transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days after transplant 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 adverse events

Secondary study objectives

Eradication rate of opportunistic CMV infections

response rate

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 specific adoptive t-cellsExperimental Treatment1 Intervention

This study involves a one-time infusion of the experimental CMV specific adoptive t-cells. After this infusion, patients will be followed for 4 weeks.

0 / 4Eligibility criteria met