Actively Recruiting
Expansion of Virus-Specific Lymphocytes for Cell Therapy in Immunosuppressed Patients Who Underwent Bone Marrow Transplantation
Led by Hospital Israelita Albert Einstein · Updated on 2024-10-24
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and tolerability of cytomegalovirus (CMV)-specific lymphocyte infusion therapy in patients who have undergone allogeneic bone marrow transplantation and experience CMV infections that do not respond to conventional treatments or where standard therapies may be toxic. The study focuses on treating CMV infections that can cause severe complications such as neurological, pulmonary, gastrointestinal, and eye problems, leading to serious illness and extended hospital stays. It explores a new cell-based therapy that may help reduce these complications and improve patient outcomes after transplantation. The treatment involves preparing CMV-specific T lymphocytes from platelet donor blood, selecting cells that respond to CMV peptides using interferon gamma capture, and freezing them for infusion. Patients will receive an intravenous infusion of these cells, with a dose of 1x10^6 CMV-specific T cells (about 1-2x10^4 cells per kilogram of body weight). The infusion can be repeated up to two times, spaced at least two weeks apart, if patients continue to meet the study criteria. This phase I, single-arm study follows strict safety and quality protocols for cell selection, testing, and administration. Participants will be closely monitored for infusion reactions and signs of graft versus host disease (GvHD) through vital signs checks during and after infusion, with follow-up visits weekly for seven weeks and additional visits at 100 days, six months, and one year post-infusion. Blood tests will assess liver and kidney function, blood counts, and immunogenicity by measuring anti-HLA antibodies. Researchers will also evaluate antiviral activity by measuring CMV viral load, clinical symptom scores, and immune response levels. Additional exams like CT scans, colonoscopy, eye exams, or biopsies may be done if needed, and cell biodistribution will be assessed. The total study duration includes long-term safety and effectiveness follow-up up to one year after treatment.
CONDITIONS
Brief Title
Expansion of Virus-Specific Lymphocytes for Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be able to provide signed informed consent.
- Must be between 18 and 75 years old at the time of signing the consent form.
- Have undergone allogeneic hematopoietic stem cell transplantation (related, unrelated, haploidentical, or cord blood transplant).
- Negative pregnancy test for women of childbearing age (or be post-menopausal over one year or surgically sterilized).
- Agree to use contraceptive methods if sexually active and of childbearing age.
- Present with clinically significant CMV infection and have one of the following: refractory CMV infection with over 1 log increase in CMV copies after 2 weeks of antiviral therapy;
- Probable refractory CMV infection with persistent CMV DNA at the same level or less than 1 log increase after 2 weeks of treatment;
- Presence of resistant CMV due to known genetic mutation reducing antiviral susceptibility;
- Refractory CMV disease with worsening symptoms or disease progression after 2 weeks of antiviral therapy;
- Restrictions or complications related to conventional therapy making it impossible, including cytopenias or nephrotoxicity related to antiviral drugs.
You will not qualify if you...
- Patients who do not meet the inclusion criteria.
- Patients who do not agree to participate or sign the consent form.
- Patients with allergy to murine antibodies or iron-dextran.
- Patients with grade 3 or 4 graft versus host disease currently active or under treatment.
- Pregnant or lactating patients.
- Patients with uncontrolled bacterial or fungal infections.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks including repeated infusions
Participants receive intravenous infusion of cytomegalovirus (CMV)-specific lymphocytes. The therapy may be repeated up to 2 times with at least 2 weeks between infusions if eligibility criteria persist.
1 infusion visit and weekly visits for 6 weeks after infusion
Duration - Up to 12 months post-infusion
Participants are monitored for safety including infusion reactions, graft versus host disease, and immunogenicity, as well as treatment effectiveness through clinical and laboratory assessments.
Visits weekly for 6 weeks, plus visits at 100 days, 6 months, and 1 year after infusion
Trial Site Locations
Total: 1 location
1
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil, 05653000
Actively Recruiting
Research Team
N
Nelson C Hamerschlak, MD, PhD
L
Luciana C Marti, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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