Can a simple pill stop a hidden virus after cancer treatment?
NCT ID NCT06575374
First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This study tests whether the drug letermovir can prevent cytomegalovirus (CMV) from reactivating in people who have received a type of CAR T-cell therapy called axicabtagene ciloleucel. CMV is a common virus that can cause serious illness when the immune system is weakened. The trial will enroll 36 adults who are CMV-positive and scheduled for this therapy, giving them letermovir by mouth or IV. The main goal is to see if the drug is safe and reduces CMV reactivation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Letermovir
- What this could lead to
- If it works, this could offer a way to prevent a common viral complication in patients receiving CAR T-cell therapy.
- What could go wrong
- This is a small, early-phase pilot trial with only 36 participants, so results may not apply broadly. Side effects are possible, and the drug may not prevent CMV as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years of age. 2. Have an ECOG performance status of 0 or 1. 3. The participant must be scheduled for SOC AXI-CEL. 4. The participant must be seropositive for CMV (defined as having anti-CMV IgG antibodies) 5. Creatinine clearance \> 10 mL/min 6. Child Pugh class A or B if liver disease is present. 7. Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. 8. Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: 1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection not responding to treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 2. Female participants who are pregnant or breastfeeding. 3. Unwilling or unable to follow protocol requirements. 4. Planned to receive any other anti-CMV therapy such as high dose acyclovir (500 mg/m2/dose intravenously every 8 hours or 800 mg orally 4 times a day) or high dose valacyclovir (2 grams three to four times daily or 2 grams three times daily) for the prophylaxis of CMV reactivation. Acyclovir or valacyclovir at lower doses for the prevention of HSV and VZV are allowed. 5. Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug. 6. Evidence for CMV infection defined as any positive CMV DNA qPCR test within 1 week prior to starting letermovir. 7. Child Pugh class C liver disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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