Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell

Launched by M.D. ANDERSON CANCER CENTER · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a drug called Letermovir to see if it can help prevent a virus called cytomegalovirus (CMV) from becoming active in patients receiving CAR T-cell therapy. CMV can cause serious health problems, especially in people with weakened immune systems, so finding ways to prevent it is important. The trial is currently looking for participants who are at least 18 years old, scheduled to receive a specific type of CAR T-cell treatment, and have previously been exposed to CMV (indicated by certain antibodies in their blood).

To participate, individuals must be in generally good health and be willing to follow the study guidelines. Participants will take Letermovir and will be monitored for any side effects or changes in their health. It’s important that women who could become pregnant agree to use birth control during the study. Those with certain medical conditions, such as uncontrolled infections or liver disease classified as severe, will not be eligible. By participating in this trial, individuals could help researchers learn more about preventing CMV reactivation, which could improve the safety and effectiveness of CAR T-cell therapy.

Gender

ALL

Eligibility criteria

• 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.