Viral Infection After HSCTPhase 1VS-TCNCT05075837
Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT
A Phase 1 study testing Virus -specific T cells in people with Viral Infection After HSCT, run by Istituto Giannina Gaslini.
Trial summary
The aim of the study is to evaluate the adverse events and the efficacy of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years)… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Viral Infection After HSCT
- What is being tested?
- Virus -specific T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2024to 25 Jul 2025
- Phase
- Phase 1
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Allogeneic transplant with any cells source and conditioning regimen
- Age between 0-21 years
- Viral infection/reactivation (CMV, EBV, ADV)
- Resistance of viral infections to treatments
- Absence of concomitant severe uncontrolled infections
- Life expectancy exceeding 30 days
Show all 10Show fewer
- Absence of acute or chronic uncontrolled Graft versus Host Disease (GvHD)
- Absence of acute kidney damage (creatinine value> 3 times the value normal with respect to age) not related to viral infection;
- Absence of severe acute liver injury (direct bilirubin> 3mg / dl or glutamic-oxaloacetic transaminase -SGOT> 500 UI/L) not related to viral infection;
- Presence of informed consent to the treatment of the patient / parent /legal guardian.
Who cannot join
- Absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test)
- Patient with severe renal and/or hepatic impairment as specified above
- Primary or secondary graft failure
- Relapse of malignant underlying disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Virus-specific T-cell Immunity for the Treatment of Some Resistant Viral Infections After Allogeneic Hematopoietic Stem Cell Transplantation(HSCT)
The aim of the study is to evaluate the adverse events and the efficacy of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-HSCT) performed at the Transplant Clinical Unit of the IRCCS G. Gaslini Institute (IGG).
Read the detailed description
The rationale for the study is based on the evidence that, despite the progress obtained in the management and prevention of viral infections in the patients who received allo-HSCT, some viral infections continue to be severe complications that may occurred before the immune recovery. Some of these viral reactivations are not responsive to the first or second line treatment and their treatment may be represent an important issue. The adoptive cellular immunotherapy based on the infusion of virus-specific T lymphocytes represent a valid therapeutic option and the quick access to this cellular therapy is crucial to prevent severe organ complications related to viral infection. In this study, the use of virus-specific T lymphocytes obtained from a seropositive family donor, briefly activated in vitro and immunomagnetically captured by their capacity to secrete IFN-gamma allows to obtain a rapidly usable T-lymphocyte population (both CD4+ and CD8+) potentially able to expand into the patient. The effectiveness, safety (peptides used are synthetic, no animal components, closed system production), good tolerance and speed of modality (less than 36 hours for production) is reported by many clinical studies.
- Conditions
- Viral Infection After HSCT
- Being tested
- Virus -specific T cells
- Keywords
- CMV, adenovirus, EBV, adoptive T cell therapy, allogeneic hematopoietic stem cell transplantation
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virus -specific T cellsBiological
The product is obtained by leukapheresis of a family donor responsive to the virus: consists of virus- specific T lymphocytes (both CD4+ and CD8+) resuspended in PBS / EDTA buffer plus 0.5% Albumin Human. The productive process lasts two consecutive days and includes two phases: a brief activation with specific viral peptide followed by immunomagnetic separation using the CliniMACS® CCS (IFNγ) capture system which allows a fast and automated separation of IFNγ secreting lymphocytes
| Study group | Role | What they receive |
|---|---|---|
| Virus-specific T cells for the treatment of active viral infections following allogeneic HSCT. | Experimental | Virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-HSCT) Receives: Biological: Virus -specific T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
To collect any adverse event defined as any significant alteration of vital signs and / or organ function, expressed in clinical, hematochemical and radiological findings according to version 5 of the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: from day +1 of infusion until day +56
Secondary outcomes (4)
Specific cell viral immunity
To evaluate the specific cell viral immunity for some virus defined as presence and number of CD3 + IFN-gamma + lymphocytes count in the patient's peripheral blood
Measured: from day +1 of infusion until day +56
Variation of viremia
To evaluate viremia variations with the measurement of viral PCR after the infusion of virus-specific T lymphocytes evaluated regularly 2 times a week.
Measured: from day +1 of infusion until day +56
Organ damage
To report any clinical and/or laboratory changes related to the viral infection
Measured: from day +1 of infusion until day +56
Overall survival
To evaluate the overall survival (OS) after virus-specific T lymphocytes
Measured: from day +56 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start27 Feb 2024 (estimated)
- Primary completion25 Jul 2024 (estimated)
- Study completion25 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Infection After HSCTStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I, open-label, single-arm, non-randomized study, monocentric.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maura Faraci, Istituto Giannina Gaslini
- Investigators
- Maura Faraci, MD, Principal investigator, Istituto G. Gaslini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075837
- Sponsor's protocol ID
- IGianninaGaslini
- Acronym
- VS-TC
- Status last verified
- Feb 2024
- First submitted
- 21 Sep 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are to be shared with hematologists and oncologists of our Institute
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virus-specific T-cell Immunity for the Treatment of Some Resistant Viral Infections After Allogeneic Hematopoietic Stem Cell Transplantation(HSCT)
- ClinicalTrials.gov ID
- NCT05075837
- Acronym / sponsor ID
- VS-TC / IGianninaGaslini
- Conditions
- Viral Infection After HSCT
- Keywords
- CMV, adenovirus, EBV, adoptive T cell therapy, allogeneic hematopoietic stem cell transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 27 Feb 2024 (estimated)
- Primary completion
- 25 Jul 2024 (estimated)
- Study completion
- 25 Jul 2025 (estimated)
- First posted
- 13 Oct 2021 (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.
The aim of the study is to evaluate the adverse events and the efficacy of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-HSCT) performed at the Transplant Clinical Unit of the IRCCS G. Gaslini Institute (IGG).
Detailed description
The rationale for the study is based on the evidence that, despite the progress obtained in the management and prevention of viral infections in the patients who received allo-HSCT, some viral infections continue to be severe complications that may occurred before the immune recovery. Some of these viral reactivations are not responsive to the first or second line treatment and their treatment may be represent an important issue. The adoptive cellular immunotherapy based on the infusion of virus-specific T lymphocytes represent a valid therapeutic option and the quick access to this cellular therapy is crucial to prevent severe organ complications related to viral infection. In this study, the use of virus-specific T lymphocytes obtained from a seropositive family donor, briefly activated in vitro and immunomagnetically captured by their capacity to secrete IFN-gamma allows to obtain a rapidly usable T-lymphocyte population (both CD4+ and CD8+) potentially able to expand into the patient. The effectiveness, safety (peptides used are synthetic, no animal components, closed system production), good tolerance and speed of modality (less than 36 hours for production) is reported by many clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I, open-label, single-arm, non-randomized study, monocentric.
| Arm | Type | Receives |
|---|---|---|
| Virus-specific T cells for the treatment of active viral infections following allogeneic HSCT. | Experimental | Biological: Virus -specific T cellsVirus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-HSCT) |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Allogeneic transplant with any cells source and conditioning regimen
- Age between 0-21 years
- Viral infection/reactivation (CMV, EBV, ADV)
- Resistance of viral infections to treatments
- Absence of concomitant severe uncontrolled infections
Key exclusion criteria (4 listed)
- Absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test)
- Patient with severe renal and/or hepatic impairment as specified above
- Primary or secondary graft failure
- Relapse of malignant underlying disease
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 |
|---|---|---|
| Virus -specific T cellsThe product is obtained by leukapheresis of a family donor responsive to the virus: consists of virus- specific T lymphocytes (both CD4+ and CD8+) resuspended in PBS / EDTA buffer plus 0.5% Albumin Human. The productive process lasts two consecutive days and includes two phases: a brief activation with specific viral peptide followed by immunomagnetic separation using the CliniMACS® CCS (IFNγ) capture system which allows a fast and automated separation of IFNγ secreting lymphocytes | Biological | Virus-specific T cells for the treatment of active viral infections following allogeneic HSCT. |
Primary outcome
Adverse events
Time frame: from day +1 of infusion until day +56
To collect any adverse event defined as any significant alteration of vital signs and / or organ function, expressed in clinical, hematochemical and radiological findings according to version 5 of the Common Terminology Criteria for Adverse Events (CTCAE)
4 secondary outcomes
Specific cell viral immunity
Time frame: from day +1 of infusion until day +56
Variation of viremia
Time frame: from day +1 of infusion until day +56
Organ damage
Time frame: from day +1 of infusion until day +56
Overall survival
Time frame: from day +56 to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No. IPD are to be shared with hematologists and oncologists of our Institute
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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. This study is not recruiting at the moment.
Maura Faraci, MD principal investigator
Istituto G. Gaslini
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Virus -specific T cells in people with Viral Infection After HSCT, run by Istituto Giannina Gaslini.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maura Faraci, MD (01056362405, maurafaraci@gaslini.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: from day +1 of infusion until day +56). 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 6 Mar 2024.