CMVPhase 2INMUNOCELLNCT04056533
Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
A Phase 2 study testing CMV CTLs in people with CMV, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CMV
- What is being tested?
- CMV CTLs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 26 Mar 2022to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- HLA haploidentical and CMV-seropositve donors.
- Donor must be checked and suitable.
- Signed writen informed consent.
- Donor without active infection evidence at leukapheresis.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lucía Lavín Alconero, Phd contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Marques de Valdecilla
Santander
enrique ocio
About this study
Official title: Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy
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 detailed 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.
- Conditions
- CMV
- Being tested
- CMV CTLs
- Keywords
- Citomegalovirus, Haploidentical, Hematopoietic Stem Cell Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV CTLsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| CMV CTLs | Experimental | 1x10^5 CMV-CTLs/kg Receives: Biological: CMV CTLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
100-days incidence of CMV infection
Viral load >200 copies in 1 sample
Measured: From date of CMV-CTLs infusion to 100 days after transplant
Secondary outcomes (2)
1-year incidence of CMV specific antiviral drug use
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.
Measured: From date of CMV-CTLs infusion to 1 year after transplant
1-year incidence of CMV disease
CMV disease P.Lungman criteria. CMV as primary cause of death.
Measured: From date of CMV-CTLs infusion to 1 year after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start26 Mar 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Galo Peralta Fernandez, MD, Study director, Instituto de Investigación Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056533
- Sponsor's protocol ID
- INMUNOCELL
- Acronym
- INMUNOCELL
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2019
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy
- ClinicalTrials.gov ID
- NCT04056533
- Acronym / sponsor ID
- INMUNOCELL / INMUNOCELL
- Conditions
- CMV
- Keywords
- Citomegalovirus, Haploidentical, Hematopoietic Stem Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 26 Mar 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMV CTLs | Experimental | Biological: CMV CTLs1x10^5 CMV-CTLs/kg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- Patients without haploidentical CMV-seropositive donors.
- Patients who are not suitable for follow up visits.
- Hematopoiesis recovery at least partial (neutrophil counts >0.5x10^9/L in at least 3 consecutive samples post-transplant).
- Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion.
- ECOG > or = 3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMV CTLsThe 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. | Biological | CMV CTLs |
Primary outcome
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
2 secondary outcomes
1-year incidence of CMV specific antiviral drug use
Time frame: From date of CMV-CTLs infusion to 1 year after transplant
1-year incidence of CMV disease
Time frame: From date of CMV-CTLs infusion to 1 year after transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucía Lavín Alconero, Phd contact
Galo Peralta Fernandez, MD study director
Instituto de Investigación Marqués de Valdecilla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CMV CTLs in people with CMV, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Sanchez-Escamilla, MD (+34646393234, msanchez@idival.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100-days incidence of CMV infection (time frame: From date of CMV-CTLs infusion to 100 days after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.