Opportunistic Fungal InfectionPhase 1/2Penta-STs-001NCT05471661
T Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus Fumigatus Infections After Allogeneic Stem Cell Transplantation
A Phase 1/2 study testing Pentavalent-specific T cells (penta-STs) in people with Opportunistic Fungal Infection and Opportunistic Viral Infection, run by George Papanicolaou Hospital at 2 sites in Greece.
Trial summary
The purpose of the study is to determine the feasibility, safety and efficacy of administering rapidly-generated donor-derived pentavalent-specific T cells (Penta-STs) to mediate antiviral and antifungal activity in hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Opportunistic Fungal Infection, Opportunistic Viral Infection, Bone Marrow Transplant Infection
- What is being tested?
- Pentavalent-specific T cells (penta-STs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesGreece
- Study dates
- 22 May 2021to 8 May 2024
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant.
- Cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: AdV, CMV, EBV, ΒΚV and AF.
- Karnofsky/Lansky score of ≥ 50.
- ANC > 500/μl.
- Bilirubin ≤ 2x*, AST < 3x*, Serum creatinine ≤ 2x*, Hemoglobin > 8.0 g/dl.
- Pulse oximetry of > 90% on room air.
Show all 9Show fewer
- Available pentavalent-specific T cells.
- Negative pregnancy test (if female of childbearing potential)
- Patient capable of providing informed consent.
Who cannot join
- Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days.
- Steroids > 0.5 mg/kg/day prednisone.
- Received donor lymphocyte infusion in last 28 days.
- GVHD ≥ grade 2.
- Active and uncontrolled relapse of malignancy.
- Patients with other uncontrolled infections
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
University General Hospital of Patras
Pátrai
George Papanikolaou Hospital - Gene and Cell Therapy Center- Hematology Dpt- Hematopoietic Stem Cell Transplant Center
Thessaloniki, 57010
About this study
Official title: Administration of Rapidly Generated Multipathogen-specific T-Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus Fumigatus Infections Post Allogeneic Stem Cell Transplant
The purpose of the study is to determine the feasibility, safety and efficacy of administering rapidly-generated donor-derived pentavalent-specific T cells (Penta-STs) to mediate antiviral and antifungal activity in hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus (AF) infection/ reactivation or with active disease.
Read the detailed description
Reconstitution of anti-viral and antifungal immunity by donor-derived antigen-specific T cells has shown promise in preventing and treating infections with CMV, or/and EBV, or/and AdV or/and BKV, HHV6 or/and AF post-transplant. However, the broader implementation of T cell immunotherapy using conventional protocols is limited and until today it was practically impossible for Greece by the cost, the complexity and the time required for virus-specific T cells (VSTs) production and by the antigenic competition between different antigens, which limits the spectrum of viruses that can be targeted in a single T cell product.
In this trial, the investigators will evaluate the feasibility, safety and efficacy of donor-derived Penta-STs infusion to allogeneic HSCT recipients with confirmed AdV, EBV, CMV, BKV and AF infection.
- Conditions
- Opportunistic Fungal Infection, Opportunistic Viral Infection, Bone Marrow Transplant Infection
- Being tested
- Pentavalent-specific T cells (penta-STs)
- Keywords
- CMV, EBV, BK virus, Adenovirus, Aspergillus Fumigatus
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentavalent-specific T cells (penta-STs)Biological
Patients will receive penta-STs in a single infusion. If they have a partial response or receive therapy post-infusion which could ablate the infused T cells they are eligible to receive up to 2 additional doses from 28 days after their first dose.
| Study group | Role | What they receive |
|---|---|---|
| Penta-STs | Experimental | Patients will receive penta-STs in a single infusion. If they have a partial response or receive therapy post-infusion which could ablate the infused T cells they are eligible to receive up to 2 additional doses from 28 days after their first dose. Receives: Biological: Pentavalent-specific T cells (penta-STs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute GvHD
The safety of cell therapy with penta-STs will be assessed according to acute and chronic GvHD grades III-IV
Measured: Within 6 weeks post the last dose of penta-STs
Chronic GvHD
The safety of cell therapy with penta-STs will be assessed according to acute and chronic GvHD grades III-IV
Measured: Within 6 months post the last dose of penta-STs
Infusion-related adverse events
The safety of cell therapy with penta-STs will be assessed according to grades ≥3 infusion-related adverse events
Measured: Within 30 days of the last dose of penta-STs
Non hematological, adverse events
The safety of cell therapy with penta-STs will be assessed according to grades ≥3 non hematological, adverse events within 30 days of the last penta-ST dose, which are not due to the preexisting infection/comorbidities or the original malignancy
Measured: Within 30 days of the last dose of penta-STs
Resolution of infection - 1
The efficacy of penta-STs will be determined based on the reduction/elimination of pathogen load in patients with infections
Measured: 12 weeks post the last dose of penta-STs
Resolution of infection - 2
The efficacy of penta-STs will be determined based on the amelioration/elimination of clinical symptoms in patients with viral disease
Measured: 12 weeks post the last dose of penta-STs
Antiviral immunity
The efficacy of penta-STs will be determined based on the reconstitution of antiviral immunity (determination of virus-specific T cells)
Measured: 12 weeks post the last dose of penta-STs
Antifungal immunity
The efficacy of penta-STs will be determined based on reconstitution of antifungal immunity (determination of Aspergillus fumigatus-specific T cells)
Measured: 12 weeks post the last dose of penta-STs
Viral reactivations or recurrence of AF infection
The efficacy of penta-STs will be determined by the absence of viral reactivations or recurrence of AF infection post penta-STs infusion
Measured: 6 months post the last dose of penta-STs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start22 May 2021
- Primary completion5 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opportunistic Fungal InfectionStudies 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
- Model description
- Patients from Hematology Department- Hematopoietic Stem Cell Transplantation Unit, George Papanikolaou Hospital and Bone Marrow Transplantation Unit of the University Hospital of Patras will be eligible to receive penta-STs as treatment for infection of one or more of the target-pathogens or for increasing pathogen load in two consecutive timepoints, following any type of allogeneic transplant. If patients are receiving steroids for treatment of GVHD or for other reasons, dosage must have been tapered to ≤0.5mg/kg prednisone (or equivalent) prior to study enrollment. Patients may not have received ATG, or Campath or other immunosuppressive monoclonal antibodies in the last 28 days.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Papanicolaou Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University General Hospital of Patras
- Responsible party
- Principal investigator, Evangelia Yannaki, George Papanicolaou Hospital
- Investigators
- Evangelia Yannaki, MD, Principal investigator, George Papanicolaou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471661
- Sponsor's protocol ID
- Penta-STs-001
- Acronym
- Penta-STs-001
- Status last verified
- Dec 2024
- First submitted
- 16 Jul 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Rapidly Generated Multipathogen-specific T-Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus Fumigatus Infections Post Allogeneic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT05471661
- Acronym / sponsor ID
- Penta-STs-001 / Penta-STs-001
- Conditions
- Opportunistic Fungal Infection, Opportunistic Viral Infection, Bone Marrow Transplant Infection
- Keywords
- CMV, EBV, BK virus, Adenovirus, Aspergillus Fumigatus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- George Papanicolaou HospitalUniversity, hospital or other
- Collaborators
- University General Hospital of Patras
- Study start
- 22 May 2021 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 25 Jul 2022 (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 purpose of the study is to determine the feasibility, safety and efficacy of administering rapidly-generated donor-derived pentavalent-specific T cells (Penta-STs) to mediate antiviral and antifungal activity in hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus (AF) infection/ reactivation or with active disease.
Detailed description
Reconstitution of anti-viral and antifungal immunity by donor-derived antigen-specific T cells has shown promise in preventing and treating infections with CMV, or/and EBV, or/and AdV or/and BKV, HHV6 or/and AF post-transplant. However, the broader implementation of T cell immunotherapy using conventional protocols is limited and until today it was practically impossible for Greece by the cost, the complexity and the time required for virus-specific T cells (VSTs) production and by the antigenic competition between different antigens, which limits the spectrum of viruses that can be targeted in a single T cell product.
In this trial, the investigators will evaluate the feasibility, safety and efficacy of donor-derived Penta-STs infusion to allogeneic HSCT recipients with confirmed AdV, EBV, CMV, BKV and AF infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients from Hematology Department- Hematopoietic Stem Cell Transplantation Unit, George Papanikolaou Hospital and Bone Marrow Transplantation Unit of the University Hospital of Patras will be eligible to receive penta-STs as treatment for infection of one or more of the target-pathogens or for increasing pathogen load in two consecutive timepoints, following any type of allogeneic transplant. If patients are receiving steroids for treatment of GVHD or for other reasons, dosage must have been tapered to ≤0.5mg/kg prednisone (or equivalent) prior to study enrollment. Patients may not have received ATG, or Campath or other immunosuppressive monoclonal antibodies in the last 28 days.
| Arm | Type | Receives |
|---|---|---|
| Penta-STs | Experimental | Biological: Pentavalent-specific T cells (penta-STs)Patients will receive penta-STs in a single infusion. If they have a partial response or receive therapy post-infusion which could ablate the infused T cells they are eligible to receive up to 2 additional doses from 28 days after their first dose. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant.
- Cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: AdV, CMV, EBV, ΒΚV and AF.
- Karnofsky/Lansky score of ≥ 50.
- ANC > 500/μl.
- Bilirubin ≤ 2x*, AST < 3x*, Serum creatinine ≤ 2x*, Hemoglobin > 8.0 g/dl.
Key exclusion criteria (6 listed)
- Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days.
- Steroids > 0.5 mg/kg/day prednisone.
- Received donor lymphocyte infusion in last 28 days.
- GVHD ≥ grade 2.
- Active and uncontrolled relapse of malignancy.
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 |
|---|---|---|
| Pentavalent-specific T cells (penta-STs)Patients will receive penta-STs in a single infusion. If they have a partial response or receive therapy post-infusion which could ablate the infused T cells they are eligible to receive up to 2 additional doses from 28 days after their first dose. | Biological | Penta-STs |
Primary outcome
Acute GvHD
Time frame: Within 6 weeks post the last dose of penta-STs
The safety of cell therapy with penta-STs will be assessed according to acute and chronic GvHD grades III-IV
Chronic GvHD
Time frame: Within 6 months post the last dose of penta-STs
The safety of cell therapy with penta-STs will be assessed according to acute and chronic GvHD grades III-IV
Infusion-related adverse events
Time frame: Within 30 days of the last dose of penta-STs
The safety of cell therapy with penta-STs will be assessed according to grades ≥3 infusion-related adverse events
Non hematological, adverse events
Time frame: Within 30 days of the last dose of penta-STs
The safety of cell therapy with penta-STs will be assessed according to grades ≥3 non hematological, adverse events within 30 days of the last penta-ST dose, which are not due to the preexisting infection/comorbidities or the original malignancy
Resolution of infection - 1
Time frame: 12 weeks post the last dose of penta-STs
The efficacy of penta-STs will be determined based on the reduction/elimination of pathogen load in patients with infections
Resolution of infection - 2
Time frame: 12 weeks post the last dose of penta-STs
The efficacy of penta-STs will be determined based on the amelioration/elimination of clinical symptoms in patients with viral disease
Antiviral immunity
Time frame: 12 weeks post the last dose of penta-STs
The efficacy of penta-STs will be determined based on the reconstitution of antiviral immunity (determination of virus-specific T cells)
Antifungal immunity
Time frame: 12 weeks post the last dose of penta-STs
The efficacy of penta-STs will be determined based on reconstitution of antifungal immunity (determination of Aspergillus fumigatus-specific T cells)
Viral reactivations or recurrence of AF infection
Time frame: 6 months post the last dose of penta-STs
The efficacy of penta-STs will be determined by the absence of viral reactivations or recurrence of AF infection post penta-STs infusion
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 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Evangelia Yannaki, MD principal investigator
George Papanicolaou Hospital
2 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 Pentavalent-specific T cells (penta-STs) in people with Opportunistic Fungal Infection and Opportunistic Viral Infection, run by George Papanicolaou Hospital at 2 sites in Greece.
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 6 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Acute GvHD (time frame: Within 6 weeks post the last dose of penta-STs). The study lists 9 primary outcomes in all. 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 27 Dec 2024.