RecruitingPhase 2NCT04056533

Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy

Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy

Sponsor

Instituto de Investigación Marqués de Valdecilla

Enrollment

15 participants

Start Date

Mar 26, 2022

Study Type

INTERVENTIONAL

Conditions

CMV

Summary

Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT. The aim to study donor derived CMV-CTLs after haploidentical HSCT (HAPLO) as prophylaxis for CMV infection in transplant patients. CMV-CTLs will be administer at day 21 (+-7 days) post-HAPLO. CMV DNA levels with quantitative PCR will be weekly monitored.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria10

Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO).
Any source of stem cells (peripheral blood or bone marrow).
CMV-seropositive donors.
Negative pregnancy test in women.
Signed writen informed consent.
DONORS:
HLA haploidentical and CMV-seropositve donors.
Donor must be checked and suitable.
Signed writen informed consent.
Donor without active infection evidence at leukapheresis.

Exclusion Criteria15

Patients without haploidentical CMV-seropositive donors.
Patients who are not suitable for follow up visits.
CMV-CTLs Infusion Criteria:
Hematopoiesis recovery at least partial (neutrophil counts >0.5x10\^9/L in at least 3 consecutive samples post-transplant).
CMV-CTLs NON-Infusion Criteria:
Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion.
ECOG > or = 3.
Organic toxicities grade > or = 3.
Patients who received ATG, donor lymphocytes or alemtuzuamb, 28 days pre-infusion.
Patients with uncontroled infection defined by fevers and/or inestability and/or infection not resolved.
Persistent fevers 3 days before infusion.
Acute Graft Versus Host Disease (GVHD) grade II-IV.
Relapse or progression after transplant and before infusion day.
CMV reactivation/infection after transplant and before infusion day.
Patients who don´t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study.

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Interventions

BIOLOGICALCMV CTLs

The donor derived cytomegalovirus specific T lymphocytes (CMV-CTL) will be transfused to the patients. The patients will receive CMV-CTL cells when their donors are sero-positive for CMV-DNA 21 days after transplant. The CMV-DNA levels will be monitored weekly for at least 100 days after the HAPLO. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive a CMV specific antiviral drug.