Infusion of virus-specific lymphocytes to treat CMV infections

Expansion of Virus-Specific Lymphocytes for Cell Therapy in Immunosuppressed Patients Who Underwent Bone Marrow Transplantation.

This study is testing a new treatment using special immune cells from blood donors to help patients with serious CMV infections who haven't responded to regular treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hospital Israelita Albert Einstein (other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06011486 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on the infusion of cytomegalovirus (CMV)-specific T lymphocytes derived from blood donors to treat patients with CMV infections who do not respond to standard therapies. The T lymphocytes are expanded and selected based on their ability to produce interferon-gamma in response to CMV peptides. The study aims to evaluate the safety and tolerability of this innovative therapy in patients who have undergone allogeneic hematopoietic stem cell transplantation and are experiencing significant CMV infections. The trial is designed as a phase I single-arm infusion study, assessing both the safety and effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 who have undergone allogeneic hematopoietic stem cell transplantation and are experiencing clinically significant CMV infections.

Not a fit: Patients who are not experiencing CMV infections or those who have not undergone stem cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with refractory CMV infections, potentially reducing morbidity and mortality associated with these infections.

How similar studies have performed: While this approach is innovative, similar studies using virus-specific T cell therapies have shown promise in treating viral infections in immunocompromised patients.

Eligibility criteria

Inclusion Criteria:

* Be able to provide signed informed consent.
* Must be between 18 and 75 years old at the time of signing the consent form
* Having undergone allogeneic hematopoietic stem cell transplantation (related, unrelated, haploidentical or cord blood transplant)
* Negative pregnancy test for women of childbearing age (non-fertile age defined as post-menopausal over one year, or surgically sterilized); Acceptance of the use of contraceptive methods by sexually active men and women of childbearing age;
* Present with clinically significant CMV infection and one of the following conditions:
* Refractory CMV infection, defined as over a 1log increase in blood or plasma CMV copies number after 2 weeks of treatment with appropriate anti-CMV medication (treatment with ganciclovir, valganciclovir, or foscarnet)
* Probable refractory CMV infection, defined as persistence of CMV DNA in blood or plasma at the same level or under 1 log increase after 2 weeks of treatment with appropriate anti-CMV medication (treatment with ganciclovir, valganciclovir, or foscarnet)
* Presence of resistant CMV, defined by the presence of a known genetic mutation that reduces susceptibility to one or more antiviral medications
* Refractory CMV disease, defined as worsening of signs and symptoms and/or progression to CMV disease after 2 weeks of appropriate antiviral therapy
* Restrictions or complications related to conventional therapy, which make it impossible to carry out conventional drug treatment defined as cytopenias with neutrophils under 1000 per microliter, platelets under 100,000 per microliter related to the use of ganciclovir or valganciclovir and nephrotoxicity with an increase of 1.5 times in the baseline creatinine with the use of foscavir.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria
* Patients who do not agree to participate in the study or sign the consent form
* Patients reporting allergy to murine antibodies or iron-dextran
* Patients with grade 3 or 4 graft versus host disease/graft versus host disease in activity/treatment
* Pregnant or lactating patients
* Patients with uncontrolled bacterial and/or fungal infections

Where this trial is running

São Paulo, São Paulo

• Hospital Israelita Albert Einstein — São Paulo, São Paulo, Brazil (RECRUITING)

Study contacts

• Principal investigator: Nelson Hamerschlak, MD, PhD — Hospital Israelita Albert Einstein
• Study coordinator: Nelson C Hamerschlak, MD, PhD

Conditions: CMV Viremia, CMV