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Clinical Trials/NL-OMON54824
NL-OMON54824
Recruiting
Phase 3

Treatment of chemo-refractory viral infections after allogeneic stem cell transplantation with multispecific T cells against CMV, EBV and AdV: A phase III, prospective, multicentre clinical trial - TRACE

Klinikum der Universität München0 sites40 target enrollmentTBD
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Conditionsvirus diseasesvirus infections10047438

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
virus diseases
Sponsor
Klinikum der Universität München
Enrollment
40
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Adult or paediatric patients (\>2 months of age) after HSCT suffering from
  • •new or reactivated CMV or EBV or AdV infection, refractory to standard
  • •antiviral treatment for two weeks (defined as \<\=1 log decrease in viral load
  • •over two weeks) as confirmed by quantitative blood PCR analysis
  • •2\. Original HSCT\-donor available with an immune response at least to the virus
  • •causing the therapy\-refractory infection
  • •3\. Written informed consent given (patient or legal representative)

Exclusion Criteria

  • •1\. Acute GvHD \> grade II or extensive chronic GvHD at time of T\-cell transfer
  • •2\. Treatment with steroids (\>1 mg/kg Prednisone equivalent) at Screening
  • •3\. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP
  • •infusion until 8 weeks post IMP infusion. In case of T\-cell depleted HSCT, a
  • •prescheduled prophylactic DLI \<\=3 x 10e5 T cells/kg BW is not considered an
  • •exclusion criteria.
  • •4\. Organ dysfunction or failure as determined by Karnofsky (age \>16 years) or
  • •Lansky (age \<\=16 years) score \<\=30%
  • •5\. Concomitant enrolment in another clinical trial interfering with the
  • •endpoints of this study

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Treatment of viral infections after stem cell Transplantation with specific immune cellschemo-refactory AdV, CMV and EBV infections after allogeneic stem cell transplantationTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2018-000853-29-ESKlinikum der Universität München149
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Treatment of viral infections after stem cell Transplantation with specific immune cellschemo-refactory AdV, CMV and EBV infections after allogeneic stem cell transplantationTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2018-000853-29-FRKlinikum der Universität München149
Recruiting
Phase 1
Treatment of chemo-refractory viral infections after allogeneic stem cell transplantation with multispecific T cells against CMV, EBV and AdV: A phase III, prospective, multicentre clinical trial (TRACE)Patients after HSCT suffering from new or reactivated CMV or EBV or AdV infection, refractory to standard antiviral treatmentTherapeutic area: Diseases [C] - Virus Diseases [C02]
CTIS2024-512321-84-00Klinikum der Universitaet Muenchen AöR111
Active, not recruiting
Phase 1
Treatment of viral infections after stem cell transplantation with specific immune cellsChemo-refactory AdV, CMV and EBV infections after allogeneic stem cell transplantationMedDRA version: 22.0Level: PTClassification code 10067859Term: Allogenic stem cell transplantationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.1Level: PTClassification code 10011831Term: Cytomegalovirus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10060931Term: Adenovirus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10015108Term: Epstein-Barr virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2018-000853-29-DEKlinikum der Universität München111
Active, not recruiting
Phase 1
Treatment of viral infections after stem cell Transplantation with specific immune cellschemo-refactory AdV, CMV and EBV infections after allogeneic stem cell transplantationMedDRA version: 22.0Level: PTClassification code 10067859Term: Allogenic stem cell transplantationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.1Level: PTClassification code 10011831Term: Cytomegalovirus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10060931Term: Adenovirus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10015108Term: Epstein-Barr virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2018-000853-29-BEKlinikum der Universität München111