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Virus Therapy

CMV-Specific T-Cells for Cytomegalovirus Infection

Phase 2

Waitlist Available

Led By Betul Oran

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Optimum therapy is defined as at least 14 days of therapy with ganciclovir, foscarnet, cidofovir, or valganciclovir for patients with disease or CMV viremia

Clinical status at enrollment to allow tapering of steroids equal to or less than 0.5 mg/kg/day of prednisone

Must not have

Active and uncontrolled relapse of malignancy

Patients with active acute GVHD grades II-IV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether white blood cells from donors who have been exposed to cytomegalovirus can help treat patients with a cytomegalovirus infection that has come back or has not gotten better despite standard therapy.

Who is the study for?

This trial is for patients with persistent or recurrent cytomegalovirus (CMV) infection despite standard therapy, including those who can't tolerate such treatments due to side effects. Eligible participants may have blood cancers, tumors, or be immunocompromised. They must not have acute graft-versus-host disease grades II-IV or other uncontrolled infections.

What is being tested?

The trial tests whether white blood cells from donors previously exposed to CMV can effectively treat patients with CMV infections that haven't improved after standard antiviral therapies like ganciclovir and foscarnet.

What are the potential side effects?

Potential side effects include immune reactions as the body adjusts to donor T-cells, which could lead to symptoms similar to flu-like illnesses, fatigue, rash, fever and potential complications in organs where CMV was present.

Eligibility Criteria

Inclusion Criteria

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

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I have been treated for CMV with specific medications for at least 14 days.

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I am on a low dose of steroids, 0.5 mg/kg/day or less.

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My antiviral treatment for CMV didn't lower the virus levels in my blood.

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My CMV infection hasn't improved despite treatment.

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I have CMV disease confirmed by tests on lung fluid or tissue samples.

Exclusion Criteria

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

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My cancer is currently growing or spreading and is not under control.

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I have moderate to severe graft-versus-host disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

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

Success, defined as R1 and R2 without treatment failure

Secondary study objectives

Disease-free survival time

Graft-versus-host disease

Overall survival time

+1 more

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: Treatment (allogeneic CMV-specific cytotoxic T-lymphocytes)Experimental Treatment1 Intervention

Patients receive allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes IV. Patients with partial response, stable disease, or progressive disease may receive an additional dose of allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes at a minimum of 2 weeks from the first infusion.

0 / 7Eligibility criteria met