Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
CMV
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - 80 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 15 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
- DONORS:
1. HLA haploidentical and CMV-seropositve donors.
2. Donor must be checked and suitable.
3. Signed writen informed consent.
4. 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.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
CMV CTLs
1x10\^5 CMV-CTLs/kg
Biological: CMV CTLs
CMV CTLs BIOLOGICAL
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
100-days incidence of CMV infection
Time frame: From date of CMV-CTLs infusion to 100 days after transplant
Viral load \>200 copies in 1 sample
Secondary measures
1-year incidence of CMV specific antiviral drug use
Time frame: From date of CMV-CTLs infusion to 1 year after transplant
If viral load \>200 copies in 2 samples or \>1000 in 1 sample, treatment with valganciclovir will be started.
Time from CMV-CTLs infusion until valganciclovir start and days of valganciclovir.
1-year incidence of CMV disease
Time frame: From date of CMV-CTLs infusion to 1 year after transplant
CMV disease P.Lungman criteria. CMV as primary cause of death.
Other measures
1-year incidence of CMV-CTLs adverse events
Time frame: From date of CMV-CTLs infusion to 1 year after transplant
Infusion reactions, causes of death, secondary graft failures and graft versus host disease (GVHD).
CMV-CTLs persistence
Time frame: From date of CMV-CTLs infusion to 2 months after infusion
Expansion of CMV-CTLs detected by flow cytometry.
Immune reconstitution post-HAPLO
Time frame: From date of transplant to day 180 post-transplant
CD3, CD4, CD8, B and NK lymphocyte counts in patient peripheral blood post-transplant (day 30, 60, 90 and 180) detected by flow cytometry.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Hospital Marques de ValdecillaSantander, SpainRecruiting
Study team and timeline
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Study start
- Mar 26, 2022 Actual
- Primary completion
- Mar 1, 2027 Estimated
- Study completion
- Dec 1, 2027 Estimated
- First posted
- Aug 14, 2019 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026