T Cell Therapy for Cytomegalovirus
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients with certain conditions requiring high doses of steroids or recent treatment with specific therapies are excluded, which might imply some restrictions. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment T Cell Therapy for Cytomegalovirus?
Research shows that using CMV-specific T cells can help rebuild the body's defense against the virus after stem cell transplants, reducing the need for antiviral drugs and preventing further virus reactivation in most patients. This approach has been effective and safe, even when using T cells from partially matched donors.12345
Is T Cell Therapy for Cytomegalovirus safe for humans?
The safety of T Cell Therapy for Cytomegalovirus is not directly addressed in the provided research articles, which focus on CAR-T cell therapy for other conditions. However, CAR-T cell therapy can have serious side effects, including infections and immune-related issues, which may be relevant to consider.678910
How is the T cell therapy for cytomegalovirus different from other treatments?
This treatment uses specially engineered T cells to target and fight the cytomegalovirus, offering a personalized approach that can restore long-lasting immunity without the need for antiviral drugs. Unlike traditional treatments, it involves the rapid generation and expansion of virus-specific T cells from the patient's own blood, making it a unique and effective option for patients who have undergone stem cell transplants.1231112
What is the purpose of this trial?
The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV.Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
Research Team
Mari H Dallas, MD
Principal Investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a one-time infusion of CMV-specific adoptive T-cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Follow-up
Participants are monitored for adverse events and response rate up to 100 days after transplant
Treatment Details
Interventions
- CMV specific adoptive t-cells
CMV specific adoptive t-cells is already approved in United States, European Union, China for the following indications:
- Investigational for CMV infections post-transplant
- Investigational for CMV infections post-transplant
- Investigational for CMV infections post-transplant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mari Dallas
Lead Sponsor