Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections

Launched by PROF. TOBIAS FEUCHTINGER · Apr 1, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for patients who have serious viral infections, specifically CMV, EBV, or AdV, after undergoing a stem cell transplant. The trial aims to see if transferring special immune cells called virus-specific T cells from the original stem cell donor can help fight off these infections when standard antiviral treatments have not worked. This study is for both children and adults who are facing these challenging infections and are at least 2 months old.

To be eligible for the trial, participants must have had a stem cell transplant and be experiencing a viral infection that hasn't improved with conventional treatment for at least two weeks. They also need to have a donor whose immune cells can recognize the virus causing the infection. Throughout the trial, participants will receive the T-cell treatment and will be closely monitored. This study is currently recruiting and is open to patients of all genders. If you're considering participating, it's important to discuss it with your healthcare provider to understand if it's the right option for you or your loved one.

Gender

ALL

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.