T-cell therapy for viral infections after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III trial investigates the efficacy of multivirus-specific T-cell transfer in patients who have undergone allogeneic stem cell transplantation and are suffering from refractory viral infections such as CMV, EBV, and AdV. The study aims to restore T-cell immunity in these immunocompromised patients, who are at high risk for life-threatening infections due to delayed immune reconstitution. Participants will receive T-cells specifically targeting the viruses causing their infections, with the goal of improving their clinical outcomes compared to standard antiviral treatments. The trial includes both adult and pediatric patients, and eligibility is based on specific criteria related to their viral load and immune response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult or paediatric patients (\> 2 months of age) after allogeneic stem cell transplantation (SCT) (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 no decrease or insignificant decrease of less than 1log 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) prior to any study-related procedures.

Exclusion Criteria:

1. Patient with acute GvHD \> grade II or extensive chronic GvHD at the time of IMP transfer
2. Patient receiving steroids (\>1 mg/kg BW Prednisone equivalent) at Screening.
3. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. Prescheduled prophylactic DLI ≤3x105 T cells/kg BW in case of T-cell depleted HSCT is not considered an exclusion criterion.
4. Patient with organ dysfunction or failure as determined by Karnofsky (patients \>16 years) or Lansky (patients ≤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 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. Female patient of child-bearing potential (i.e. post menarche and not surgically sterilized) or male patient 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 ≤7 days before IMP administration on Day 0. Acceptable birth control methods are hormonal oral contraceptive ('pill'), contraceptive injection or patch, intrauterine pessar or the combination of two barrier methods. The combination of female and male condomes is NOT acceptable. If the male partner is sterilized, no further contraceptive is required. Women of post-menopausal status (no menses for 12 months without an alternative medical cause) are also not required to use contraceptives during the study.
11. Known hypersensitivity to iron dextran
12. Patients unwilling or unable to comply with the protocol or unable to give informed consent.

Where it's running

• Institut Jules Bordet (JBI)
  Brussels, Belgium Recruiting
• UZ Brussel
  Brussels, Belgium Recruiting
• Ghent Universal Hospital (UZG)
  Ghent, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• Université de Liège (ULG)
  Liège, Belgium Recruiting
• Hôpital Jeanne de Flandre, CHU Lille
  Lille, France Recruiting

Study contacts

• Principal investigator: Tobias Feuchtinger, Prof — Medical Center - University of Freiburg
• Study coordinator: Tobias Feuchtinger, Prof
• Email: kjk.trace-study@uniklinik-freiburg.de
• Phone: 0049 (0)761 270

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.