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 Universitaet Muenchen AöR0 sites111 target enrollmentMay 28, 2024

ConditionsPatients after HSCT suffering from new or reactivated CMV or EBV or AdV infection, refractory to standard antiviral treatment Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients after HSCT suffering from new or reactivated CMV or EBV or AdV infection, refractory to standard antiviral treatment
Sponsor: Klinikum der Universitaet Muenchen AöR
Enrollment: 111
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 28, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Klinikum der Universitaet Muenchen AöR

Eligibility Criteria

Inclusion Criteria

•Adult or paediatric patients (\>2 months of age) after HSCT (no time restrictions apply) 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, Original HSCT\-donor available with an immune response at least to the virus causing the therapy\-refractory (\=underlying) infection, Written informed consent given (patient or legal representative)

Exclusion Criteria

•Acute GvHD \> grade II or extensive chronic GvHD at time of IMP transfer, 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, Known hypersensitivity to iron dextran, Patients unwilling or unable to comply with the protocol or unable to give informed consent, Treatment with steroids (\>1 mg/kg Prednisone equivalent) at Screening, 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 10^5 T cells/kg BW is not considered an exclusion criteria., Organ dysfunction or failure as determined by Karnofsky (age \>16 years) or Lansky (age \=16 years) score \=30%, Concomitant enrolment in another clinical trial interfering with the endpoints of this study, Any medical condition which could compromise participation in the study according to the investigator’s assessment, 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, 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, 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

Outcomes

Primary Outcomes

Not specified

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