Prospective clinical trial for the evaluation of safety and efficacy of virus-specific T-cells for the prevention or treatment of cytomegaly or Epstein-Barr virus infection in patients after allogeneic stem cell transplantation. The treatment will be compared to standard treatment. The allocation to treatment arms is done randomly. The trial will be conducted at several study sites.

Prospective, open-label, randomised, two-arm, controlled, multicentre clinical trial, phase I/IIa, for the evaluation of safety and efficacy of an adoptive immunotherapy with allogeneic CMV-/EBV-specific peptide-stimulated T-cells (CD3+) for the prevention or treatment of reactivation of 'CMV and/or EBV in patients after allogeneic HLA-identical stem cell transplantation - MULTIVIR01

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004240-30-DE

Enrollment

Registered

2013-12-02

Start date

2014-06-18

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Immune deficiency after allogeneic stem cell transplantation MedDRA version: 19.0 Level: PT Classification code 10007877 Term: Cell-mediated immune deficiency System Organ Class: 10021428 - Immune system disorders

Interventions

Trade Name: N.A. Product Name: Allogeneic CMV-/EBV-specific peptide-stimulated T-cells (CD3+) solution for injection Product Code: N.A. Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female person of 18 to 75 years of age • Unlimited ability to provide informed consent • Written informed consent • Indication for allogeneic stem cell transplantation • HLA-identical donor, related or unrelated, HLA match: 10/10 • Stem cell source: G-CSF mobilised peripheral blood stem cells • Positive EBV serology of the donor • Positive CMV serology of the donor • Effective contraception for females of child-bearing potential 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • Donor seronegative for EBV • Donor seronegative for CMV • Bone marrow or umbilical blood as stem cell source • Alemtuzumab (Campath®) for conditioning • Sorror score >3 • Known hypersensitivity to one of the ingredients of the IMP • Pregnant or breast-feeding female

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the safety and tolerability of an adoptive immunotherapy with CMV-/EBV-specific peptide-stimulated T-cells (CD3+) for prevention or treatment of the reactivation of CMV or EBV infection in patients after allogeneic HLA-identical stem cell transplantation.;Secondary Objective: • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the occurrence of CMV and/or EBV reactivation in patients after allogeneic stem cell transplantation. • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the utilisation of anti-CMV medication (ganciclovir, valganciclovir, foscavir, cidofovir). • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the utilisation of rituximab after EBV reactivation. • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the reconstitution of the T-cell compartment.;Primary end point(s): Primary safety endpoints: Occurrence of acute toxicity, such as an allergic or anaphylactic reaction ( CTCAE Grade =2 ) , within 72 hours after administration of the IMP • De novo onset of acute GVHD within 14 days after administration of the IMP. Criteria : Staging and grading according to Glucksberg • occurrence of an aggravation of pre-existing acute GvHD (persistent acute GvHD ) within 14 days after administration of the IMP. Criteria: Staging and grading according to Glucksberg;Timepoint(s) of evaluation of this end point: At all visits during the observation period	—

Measure

Time frame

Main Objective: Evaluation of the safety and tolerability of an adoptive immunotherapy with CMV-/EBV-specific peptide-stimulated T-cells (CD3+) for prevention or treatment of the reactivation of CMV or EBV infection in patients after allogeneic HLA-identical stem cell transplantation.;Secondary Objective: • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the occurrence of CMV and/or EBV reactivation in patients after allogeneic stem cell transplantation. • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the utilisation of anti-CMV medication (ganciclovir, valganciclovir, foscavir, cidofovir). • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the utilisation of rituximab after EBV reactivation. • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the reconstitution of the T-cell compartment.;Primary end point(s): Primary safety endpoints: Occurrence of acute toxicity, such as an allergic or anaphylactic reaction ( CTCAE Grade =2 ) , within 72 hours after administration of the IMP • De novo onset of acute GVHD within 14 days after administration of the IMP. Criteria : Staging and grading according to Glucksberg • occurrence of an aggravation of pre-existing acute GvHD (persistent acute GvHD ) within 14 days after administration of the IMP. Criteria: Staging and grading according to Glucksberg;Timepoint(s) of evaluation of this end point: At all visits during the observation period

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Secondary

Measure	Time frame
Secondary end point(s): Occurrence of at least one CMV reactivation during the observation period • Occurrence of at least one EBV reactivation during the observation period • Occurrence of CMV viral load requiring treatment within the observation period • Occurence of EBV viral load requiring treatment within the observation period • Quantitative detection of EBV-specific T- cells at the time 204 ± 7 days after SZT • Quantitative detection of CMV-specific T cells at the time of 204 ± 7 days after SZT • Consumption of Antivirals ganciclovir / valganciclovir / foscavir / cidofovir within the observation period • Consumption of rituximab in EBV reactivation within the observation period;Timepoint(s) of evaluation of this end point: All during the observation period	—

Measure

Time frame

Secondary end point(s): Occurrence of at least one CMV reactivation during the observation period • Occurrence of at least one EBV reactivation during the observation period • Occurrence of CMV viral load requiring treatment within the observation period • Occurence of EBV viral load requiring treatment within the observation period • Quantitative detection of EBV-specific T- cells at the time 204 ± 7 days after SZT • Quantitative detection of CMV-specific T cells at the time of 204 ± 7 days after SZT • Consumption of Antivirals ganciclovir / valganciclovir / foscavir / cidofovir within the observation period • Consumption of rituximab in EBV reactivation within the observation period;Timepoint(s) of evaluation of this end point: All during the observation period

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Countries

Germany

Contacts

Public ContactMedizinische Klinik Hämatologie

Charité Campus Virchow-Klinikum

armin.gerbitz@charite.de+49030450 565256

Outcome results

None listed

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