CMV-Specific CTLs for CMV Infection Post-Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how well special donor immune cells, known as Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes, can combat infections by two viruses, CMV and AdV, which may recur after a transplant. Researchers aim to determine if these donor cells can safely and effectively reduce these infections. Individuals who have undergone a stem cell or organ transplant and are experiencing a CMV or AdV infection, particularly if they cannot tolerate standard antiviral treatments, might be suitable candidates for this trial. As an Early Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants a chance to be among the first to receive this innovative therapy.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have received certain T-cell depleting agents or high doses of steroids recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using CMV-specific immune cells is generally safe for patients. One study found that these cells can help manage difficult CMV infections in transplant recipients, suggesting the treatment works without major side effects.
For adenovirus-specific immune cells, the safety information remains less clear. As this trial is in the early stages, researchers are still collecting safety data. Early trials focus on ensuring treatments are safe, so researchers carefully monitor participants for any issues.12345Why are researchers excited about this trial's treatments?
Unlike standard antiviral medications for cytomegalovirus (CMV) infections post-transplant, which often come with side effects and resistance issues, CMV-specific cytotoxic T lymphocytes (CTLs) offer a more targeted approach. These CTLs are immune cells specifically engineered to hunt down and destroy CMV-infected cells, potentially providing a more precise and effective treatment. Additionally, this approach can be tailored to the individual's immune system, which might lead to fewer side effects and better outcomes. Researchers are excited about this treatment because it harnesses the body's own immune system to fight the infection more naturally and directly.
What evidence suggests that this trial's treatments could be effective for CMV or AdV infection post-transplant?
Research has shown that special immune cells from donors, called CMV-specific CTLs, can effectively treat CMV infections. In this trial, participants will receive these CMV-specific CTLs, which safely locate and destroy the virus in transplant patients. Studies have found that patients treated with these cells often experience a resolution of their CMV infections, offering promise for managing the virus post-transplant. This treatment has been successfully used in adults who have received stem cell transplants, enhancing the body's natural ability to combat viral infections. Another arm of this trial involves participants receiving AdV-specific CTLs, targeting adenovirus infections.12346
Who Is on the Research Team?
Sumithira Vasu, MBBS
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals who have had a stem cell or solid organ transplant and are experiencing CMV reactivation despite standard treatment. Participants must be at least 30 days post-transplant, with persistent CMV viremia, and not on high doses of steroids or T-cell depleting agents. A suitable donor must be haploidentical and CMV seropositive.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive allogeneic cytomegalovirus-specific or adenovirus-specific cytotoxic T lymphocytes intravenously. Participants with persistent infection are eligible for a second infusion after 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments for adverse events and viral reactivations.
What Are the Treatments Tested in This Trial?
Interventions
- Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sumithira Vasu
Lead Sponsor