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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)
EU CTIS ID: 2024-512321-84-00
What this study is testing
Evaluation of efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after allogeneic stem cell transplantation
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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.
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.