Treatment of chemo-refractory viral infections after allogeneicstem cell transplantation with multispecific T cells against CMV, EBV and AdV: A phase III, prospective, multicentre clinical trial - Multivirus-specific T-cell transfer post SCT vs AdV, CMV and EBV infections (TRACE)

Klinikum der Universität München0 sites111 target enrollmentApril 9, 2020

Conditionschemo-refactory AdV, CMV and EBV infections after allogeneic stem cell transplantation MedDRA version: 22.0Level: PTClassification code 10067859Term: Allogenic stem cell transplantationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.1Level: PTClassification code 10011831Term: Cytomegalovirus infectionSystem Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1Level: PTClassification code 10060931Term: Adenovirus infectionSystem Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1Level: PTClassification code 10015108Term: Epstein-Barr virus infectionSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: chemo-refactory AdV, CMV and EBV infections after allogeneic stem cell transplantation
Sponsor: Klinikum der Universität München
Enrollment: 111
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 9, 2020

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Klinikum der Universität München

Eligibility Criteria

Inclusion Criteria

•1\. Adult or paediatric patients (\>2 months of age) after HSCT (no time restrictions apply) suffering from new or reactivated CMV, EBV or AdV infection and 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 (\=underlying) infection
•3\. Written informed consent given (patient or legal representative)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 111
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 46
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 5

Exclusion Criteria

•1\. Acute GvHD \> grade II or extensive chronic GvHD at time of IMP 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
•6\. Any medical condition which could compromise participation in the study according to the investigator’s assessment
•7\. Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study
•8\. Second line or experimental antiviral treatment other than Ganciclovir/Valganciclovir, Foscarnet, Cidofovir and Rituximab from Screening until 8 weeks after IMP infusion or prophylactic treatment other than Aciclovir or Letermovir throughout the study except approved by sponsor
•9\. Known HIV infection. In case patients do not have a negative HIV test performed within 6 months before enrolment in the study, HIV negativity has to be confirmed by a negative laboratory test.
•10\. Female patient who is pregnant or breast\-feeding, or adult of reproductive potential not willing to use an effective method of birth control from Screening until the last follow\-up visit (FU6, Visit 8\) Note: women of childbearing potential must have a negative serum pregnancy test at study entry