T lymphocytes to simultaneously kill 3 viruses (CMV, EBV, BK) after allogeneic stem cell transplantation

Administration of Rapidly Generated Multivirus-Specific Cytotoxic TLymphocytes for the Treatment of CMV, EBV, and BK virus Infections post Allogeneic Stem Cell Transplant - Tri-VSTs-001

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004817-98-GR

Enrollment

Registered

2019-05-29

Start date

2019-06-25

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections from EBV, CMV and BK virus post allogeneic Stem Cell Transplant

Interventions

Product Name: ??t?-???? ?-?eµf???tta?a t??p??? e?d???t?ta? Product Code: ?ri-VSTs-001 Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Prior myeoloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells from unrelated or haploidentical donors 2. Treatment of one or multiple infections/reactivations of at least one of the targeted viruses: CMV, EBV, BK virus 3. Karnofsky/Lansky score of = 50 4. ANC > 500/µl 5. Bilirubin = 2x*, AST 8.0 g/dl 6. Pulse oximetry of > 90% on room air 7.Available virus-specific T cells 8. Negative pregnancy test in female patients if applicable 9.Written informed consent and/or signed assent line from patient, or guardian Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients receiving ATG, or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment. • Patients with other uncontrolled infections (see protocol chapter 2.3.2) • Patients receiving steroids: >0.5mg/kg/daily prednisone • Patients who received donor lymphocyte infusion (DLI) within 28 days. •Patients with active acute GVHD grades II-IV. •Active and uncontrolled relapse of malignancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and efficacy of administering virus-specific T cells (VSTs) as treatment for viral infections at Greece and the feasibility of the approach in Greece;Secondary Objective: To determine i) the frequency of reactivations by the targeted virus for which the VSTs were infused, ii) the frequency of reactivations by the rest of targeted viruses post VST infusion and iii) the probability of disease relapse throughout the follow up period ;Primary end point(s): 1) Feasibility and safety of cell therapy with VSTs. The safety end point will be assessed based on: i) development of de novo GvH or progression to acute GvHD grades III-IV, ii) development of grades 3-5 infusion-related adverse events and iii) grades 4-5 nonhematological adverse events that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities 2) Efficacy of VSTs will be assesed based on: • viral load • anti-viral immune reconstitution • viral reactivations;Timepoint(s) of evaluation of this end point: 1)Safety: •development of de novo GvH or progression to acute GvHD of grade III-IV within 42 days post last infusion of VSTs, •development of grade 3-5 infusion-related adverse events and grade 4-5 nonhematological adverse events that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbiditieswithin 30 days post last infusion of VSTs 2)Efficacy: weeks 1,2,4,6 and 8, and month 3. Additional timepoints if clinically relevant	—

Measure

Time frame

Main Objective: To evaluate the safety and efficacy of administering virus-specific T cells (VSTs) as treatment for viral infections at Greece and the feasibility of the approach in Greece;Secondary Objective: To determine i) the frequency of reactivations by the targeted virus for which the VSTs were infused, ii) the frequency of reactivations by the rest of targeted viruses post VST infusion and iii) the probability of disease relapse throughout the follow up period ;Primary end point(s): 1) Feasibility and safety of cell therapy with VSTs. The safety end point will be assessed based on: i) development of de novo GvH or progression to acute GvHD grades III-IV, ii) development of grades 3-5 infusion-related adverse events and iii) grades 4-5 nonhematological adverse events that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities 2) Efficacy of VSTs will be assesed based on: • viral load • anti-viral immune reconstitution • viral reactivations;Timepoint(s) of evaluation of this end point: 1)Safety: •development of de novo GvH or progression to acute GvHD of grade III-IV within 42 days post last infusion of VSTs, •development of grade 3-5 infusion-related adverse events and grade 4-5 nonhematological adverse events that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbiditieswithin 30 days post last infusion of VSTs 2)Efficacy: weeks 1,2,4,6 and 8, and month 3. Additional timepoints if clinically relevant

—

Secondary

Measure	Time frame
Secondary end point(s): non applicable;Timepoint(s) of evaluation of this end point: non applicable	—

Countries

Greece

Contacts

Public ContactG?a????? ??a??e??a

??µat??????? ???????, ????da ?etaµ?s?e?s?? ??µ?p???t???? ??tt????, ??s???µe?? G. ?apa????????, Tessa??????

eyannaki@u.washington.edu+302313307518

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026