Trials / Completed
CompletedNCT04018261
Virus-specific Activated T Lymphocytes From a Donor in Hematopoietic Progenitor Transplanted Patients
A Prospective Multicenter Open-label, Not Controlled Phase Ib-II Clinical Trial to Assess the Safety and Immunologic Efficacy of Virus-specific T Lymphocytes From the Best Donor in Receptors of Hematopoietic Progenitor Allogeneic Transplant
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Banc de Sang i Teixits · Academic / Other
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
Marrow transplanted immunocompromised patients with cytomegalovirus (CMV) viral infection will be treated with CMV activated T-Lymphocytes. T-Lymphocytes will be obtained through an apheresis from a compatible donor. Safety and immunoreconstitution parameters in blood samples will be assessed up to +60 days after the treatment.
Detailed description
A prospective, multicentre, open-label and uncontrolled phase Ib-II clinical trial in which a total of 20 patients ≥ 1 year of age with an allogeneic transplant of hematopoietic progenitors and post-transplant CMV infection will be included. The main objective is to evaluate the safety of the infusion of CMV activated T-lymphocytes and secondary objectives are to evaluate the efficacy through clinical evolution, viral load, ability to induce immunoreconstitution against the virus and evaluation of the persistence of specific T cells. The treatment will be administered intravenously (central or peripheral route) in a single dose at a dose of 0.01-5 E4 specific virus T lymphocytes per Kg of receptor weight. After the infusion, patients will follow periodic controls (+7, +14, +21, +28, +45 and +60 days) in which a clinical evaluation will be performed and blood samples will be obtained in order to evaluate the persistence of specific T cells in the recipient:
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Activated T-Lymphocytes | Activated T-Lymphocytes will be infused intravenously in a single-dose |
Timeline
- Start date
- 2019-07-04
- Primary completion
- 2021-10-18
- Completion
- 2021-10-18
- First posted
- 2019-07-12
- Last updated
- 2024-01-24
Locations
7 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04018261. Inclusion in this directory is not an endorsement.