Actively Recruiting
Expansion of Virus-Specific Lymphocytes for Cell Therapy
Led by Hospital Israelita Albert Einstein · Updated on 2024-10-24
10
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Infections and reactivation of human cytomegalovirus (CMV), adenovirus, Epstein-barr and polyoma virus infections are frequent causes of morbidity and mortality and are a source of serious complications in patients undergoing allogeneic bone marrow transplantation. In this project we will prepare specific T lymphocytes from blood donor, select cells CMV-specific by interferon gamma capture and treat patients with CMV viral infections. These cells will be used as antiviral therapy in transplanted patients whom do not respond to conventional therapies or in patients whose conventional therapy may be toxic in the context of transplantation. In this context, CMV reactivation can lead to serious complications in patients, such as irreversible neurological changes, pulmonary, gastrointestinal and ophthalmologic complications, among others, in addition to prolonged hospitalizations, leading to significant morbidity and mortality , both in the health sector public as private. This project may represent an important therapeutic modality using cell of the shelf as a source of therapy for different patients and contributing to reduced morbidity / mortality after transplantation, as well as a reduction in the hospitalization period.
CONDITIONS
Official 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.
- Be between 18 and 75 years old at the time of consent.
- Have undergone allogeneic hematopoietic stem cell transplantation (related, unrelated, haploidentical or cord blood).
- For women of childbearing age, have a negative pregnancy test and agree to use contraception; men and women sexually active must agree to contraception.
- Have clinically significant CMV infection with one of the following: refractory CMV infection (over 1 log increase in CMV copies after 2 weeks of treatment), probable refractory CMV infection (persistent CMV DNA with less than 1 log increase after 2 weeks), resistant CMV defined by genetic mutation, or refractory CMV disease with worsening symptoms after 2 weeks of antiviral therapy.
- Have complications or restrictions to conventional therapy making drug treatment impossible, such as neutropenia (neutrophils under 1000/µL), thrombocytopenia (platelets under 100,000/µL) due to certain antivirals, or nephrotoxicity with increased creatinine linked to foscarnet use.
You will not qualify if you...
- Not meeting the inclusion criteria.
- Refusal or inability to sign informed consent.
- Allergy to murine antibodies or iron-dextran.
- Presence of grade 3 or 4 graft versus host disease or active GvHD under treatment.
- Pregnancy or breastfeeding.
- Uncontrolled bacterial or fungal infections.
AI-Screening
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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
CONTACT
L
Luciana C Marti, PhD
CONTACT
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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