Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy (INMUNOCELL)

  • End date
    Mar 1, 2026
  • participants needed
  • sponsor
    Instituto de Investigación Marqués de Valdecilla
Updated on 27 May 2022


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.


In HAPLO, CMV infection and disease are more frequent than in other type of HSCT, this is related to delayed immune reconstitution after transplant increasing post-transplant infectious complications. Approximately 60% of patients reactivated CMV infection after HAPLO and 15%, developed CMV disease afecting organs and causing the death of the patient in 8% of CMV disease cases.

If patient and donor are eligible, it will take 1x10^9 cells from donor leukapheresis. Donor cells will be selected and procesed by CliniMACs PRODIGY and after 12h it will obtain 7mL of CMV-CTLs. It will use 6mL of CMV-CTLs to infused a dose of 1x10^5 cells/kg in our patient. The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The patients will receive the dose of CMV-CTL cells when they are sero-positive for CMV-DNA 21 (+- 7 days) days after transplant.

The CMV-DNA levels will be monitored weekly for at least 100 days after the transplant. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then the patient will receive treatment with anti-CMV comercial drugs.

Condition CMV
Treatment CMV CTLs
Clinical Study IdentifierNCT04056533
SponsorInstituto de Investigación Marqués de Valdecilla
Last Modified on27 May 2022


Yes No Not Sure

Inclusion Criteria

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
HLA haploidentical and CMV-seropositve donors
Donor must be checked and suitable
Signed writen informed consent
Donor without active infection evidence at leukapheresis

Exclusion Criteria

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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