CMV ViremiaPhase 1/2NCT04018261
Virus-specific Activated T Lymphocytes From a Donor in Hematopoietic Progenitor Transplanted Patients
A Phase 1/2 study testing Activated T-Lymphocytes in people with CMV Viremia and Immunosuppression-related Infectious Disease, run by Banc de Sang i Teixits at 7 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- CMV Viremia, Immunosuppression-related Infectious Disease
- What is being tested?
- Activated T-Lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 7 sitesSpain
- Study dates
- 4 Jul 2019to 18 Oct 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recipient of an allogeneic hematopoietic progenitors cell transplant (irrespectively of the donor source, donor type conditioning and underlying disease) that is beyond the day +30 of the procedure
- Patient with post-transplant infection due to CMV refractory or resistant to optimal pharmacological treatment. Specifically, the patient must be included in any of the following cases
- Patient with organic disease caused by CMV (confirmed by histology) resistant to antiviral first line treatment
- Patient with CMV reactivation and no organic disease, resistant or intolerant to 2 previous antiviral treatment lines (ganciclovir/valganciclovir and foscarnet) or not candidate to be treated due to not acceptable expected toxicity (severe renal insufficiency, neutropenia or severe thrombopenia) It is agreed that the patient is affected with a resistant CMV infection if the CMV copies doesn't decrease in > 1 log in total blood or otherwise the absolute number of copies > 1x10E4/mL in total blood after 2 weeks of antiviral treatment.
- Patients with reactivation of recurrent CMV despite correct anti-CMV treatment. It will be considered a recurrent CMV infection if the patient has > 2 reactivations in a period <6 months despite having received correct anti-CMV treatment
- Documented genetic mutations associated with ganciclovir or foscarnet resistance
Show all 9Show fewer
- ≥ 1 year of age
- Estimated life expectancy > 30 days
- Signature of the informed consent form
Who cannot join
- Acute graft-versus-host disease (GVHD) ≥ grade II or chronic ≥ moderate
- Corticosteroid ≥ 0.5mg/kg regardless the indication
- Disease relapse at the time of infection or at any time after the Allogeneic transplant.
- Severe renal disease (creatinine > 3gr/dL)
- Severe hepatic disease (bilirubin >3mg/dL or aspartate aminotransferase (AST) >500 U/L) except if it is secondary to the viral infection.
- Having received a donor lymphocytes infusion or any cell therapy product within 60 days prior to inclusion in the study (with the exception of transfusions), or having it planned within the next 60 days.
Show all 11Show fewer
- Alteration of the general condition, infection or clinical or hemodynamic instability that, in the opinion of the researcher, does not recommend the use of T cells
- Known hypersensitivity to murine proteins or iron dextran.
- Positive serology to human immunodeficiency virus (HIV), hepatitis B virus (HBV) (HBsAg, HBcAc), hepatitis C virus (HCV) and/or syphilis
- Pregnant, lactating or women without adequate contraception
- Participation in a clinical trial with investigational medicinal products the last 30 days
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
ICO Badalona
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
ICO l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario La Fe
Valencia, 46026
About this study
Official title: 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
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.
Read the 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:
- Being tested
- Activated T-Lymphocytes
- Keywords
- CMV, Bone marrow transplant, Activated T-Lymphocytes, Cell therapy, Virus infection, immunosuppression
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated T-LymphocytesDrug
Activated T-Lymphocytes will be infused intravenously in a single-dose
| Study group | Role | What they receive |
|---|---|---|
| Activated T-Lymphocytes | Experimental | Allogeneic T-Lymphocytes obtained from apheresis activated against CMV. Receives: Drug: Activated T-Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment: Adverse events
Adverse events
Measured: 60 days
Secondary outcomes (5)
Polymerase chain reaction (PCR)
Quantitative viral load
Measured: +7, +14, +21, +28, +45, +60 days
IFN-γ+ spot forming cells
Immune reconstitution by Elispot
Measured: +7, +14, +28, +60 days
Lymphocyte subpopulations
Immune reconstitution by flow cytometry
Measured: +7, +14, +28, +60 days
T-cell persistence by chimerism
Detection of donor cellularity (administered product) in the receptor serum
Measured: +14, +28 days
Time elapsed in identifying the donor
Time elapsed between the patient's inclusion in the trial and confirmation of the donor
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start4 Jul 2019
- Primary completion18 Oct 2021
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV ViremiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banc de Sang i Teixits
- Sponsor type
- University, hospital or other
- Collaborators
- Vall d'Hebron Institute of Oncology, Hospital Universitario La Fe
- Responsible party
- Sponsor
- Investigators
- Pere Barba, MD, PhD, Principal investigator, VHIO (Vall d'Hebron Institute of Oncology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018261
- Sponsor's protocol ID
- BST-LT-01
- Status last verified
- Jan 2024
- First submitted
- 9 Jul 2019
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04018261
- Acronym / sponsor ID
- BST-LT-01
- Keywords
- CMV, Bone marrow transplant, Activated T-Lymphocytes, Cell therapy, Virus infection, immunosuppression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Banc de Sang i TeixitsUniversity, hospital or other
- Collaborators
- Vall d'Hebron Institute of Oncology, Hospital Universitario La Fe
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 12 Jul 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.
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:
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activated T-Lymphocytes | Experimental | Drug: Activated T-LymphocytesAllogeneic T-Lymphocytes obtained from apheresis activated against CMV. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Recipient of an allogeneic hematopoietic progenitors cell transplant (irrespectively of the donor source, donor type conditioning and underlying disease) that is beyond the day +30 of the procedure
- Patient with post-transplant infection due to CMV refractory or resistant to optimal pharmacological treatment. Specifically, the patient must be included in any of the following cases
- ≥ 1 year of age
- Estimated life expectancy > 30 days
- Signature of the informed consent form
Key exclusion criteria (11 listed)
- Acute graft-versus-host disease (GVHD) ≥ grade II or chronic ≥ moderate
- Corticosteroid ≥ 0.5mg/kg regardless the indication
- Disease relapse at the time of infection or at any time after the Allogeneic transplant.
- Severe renal disease (creatinine > 3gr/dL)
- Severe hepatic disease (bilirubin >3mg/dL or aspartate aminotransferase (AST) >500 U/L) except if it is secondary to the viral infection.
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 |
|---|---|---|
| Activated T-LymphocytesActivated T-Lymphocytes will be infused intravenously in a single-dose | Drug | Activated T-Lymphocytes |
Primary outcome
Safety assessment: Adverse events
Time frame: 60 days
Adverse events
5 secondary outcomes
Polymerase chain reaction (PCR)
Time frame: +7, +14, +21, +28, +45, +60 days
IFN-γ+ spot forming cells
Time frame: +7, +14, +28, +60 days
Lymphocyte subpopulations
Time frame: +7, +14, +28, +60 days
T-cell persistence by chimerism
Time frame: +14, +28 days
Time elapsed in identifying the donor
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Blood and Tissue Bank of CataloniaLink provided by the sponsor.
- Vall d'Hebron Institute of OncologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for CMV Viremia
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
RecruitingPhase 2/3
Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
CMV Viremia, Heart Transplant Infection
Active, not recruitingPhase 1
CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant
Accelerated Phase CML, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia in Remission
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. This study is not recruiting at the moment.
Pere Barba, MD, PhD principal investigator
VHIO (Vall d'Hebron Institute of Oncology)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Activated T-Lymphocytes in people with CMV Viremia and Immunosuppression-related Infectious Disease, run by Banc de Sang i Teixits at 7 sites 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment: Adverse events (time frame: 60 days). 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 24 Jan 2024.