NCT04832607 Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections
| NCT ID | NCT04832607 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tobias Feuchtinger |
| Condition | AdV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 149 participants |
| Start Date | 2019-08-27 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 149 participants in total. It began in 2019-08-27 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults.
Eligibility Criteria
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.
Contact & Investigator
Tobias Feuchtinger, Prof
PRINCIPAL INVESTIGATOR
Medical Center - University of Freiburg
Frequently Asked Questions
Who can join the NCT04832607 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, studying AdV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04832607 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 149 participants.
Is NCT04832607 currently recruiting?
Yes, NCT04832607 is actively recruiting participants. Contact the research team at kjk.trace-study@uniklinik-freiburg.de for enrollment information.
Where is the NCT04832607 trial being conducted?
This trial is being conducted at Brussels, Belgium, Brussels, Belgium, Ghent, Belgium, Leuven, Belgium and 11 additional locations.
Who is sponsoring the NCT04832607 clinical trial?
NCT04832607 is sponsored by Tobias Feuchtinger. The principal investigator is Tobias Feuchtinger, Prof at Medical Center - University of Freiburg. The trial plans to enroll 149 participants.