Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT

Launched by ISTITUTO GIANNINA GASLINI · Oct 8, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option called adoptive T-cell therapy for young patients aged 0 to 21 years who have developed certain viral infections, like Adenovirus, Epstein Barr virus, or Cytomegalovirus, after receiving a stem cell transplant from a donor. The goal is to see how well this therapy works and what side effects patients might experience. The treatment involves using T cells, which are a type of white blood cell that helps fight infections, specially chosen from a family donor to target these viral infections that don’t respond well to standard treatments.

To be eligible for this trial, patients must have had an allogeneic transplant (which means their stem cells came from someone else), be between 0 and 21 years old, and have a resistant viral infection. They should also be in stable health, with no severe uncontrolled infections or serious issues with their kidneys or liver. If they qualify, participants will receive this new treatment and be monitored closely for any side effects and how well the therapy works. It's important to note that the trial is not currently recruiting participants, so it’s still in the early stages. Parents or guardians need to give their informed consent for their child to participate.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Allogeneic transplant with any cells source and conditioning regimen
• • Age between 0-21 years
• • Viral infection/reactivation (CMV, EBV, ADV)
• • Resistance of viral infections to treatments
• • Absence of concomitant severe uncontrolled infections
• • Life expectancy exceeding 30 days
• • Absence of acute or chronic uncontrolled Graft versus Host Disease (GvHD)
• • Absence of acute kidney damage (creatinine value\> 3 times the value normal with respect to age) not related to viral infection;
• • Absence of severe acute liver injury (direct bilirubin\> 3mg / dl or glutamic-oxaloacetic transaminase -SGOT\> 500 UI/L) not related to viral infection;
• • Presence of informed consent to the treatment of the patient / parent /legal guardian.
• Exclusion Criteria:
• • Absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test)
• • Patient with severe renal and/or hepatic impairment as specified above
• • Primary or secondary graft failure
• • Relapse of malignant underlying disease