Ignite Creation Date:
2024-05-06 @ 8:55 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02851576
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2016-07-28
Brief Title:
Clinical Grade Adenovirus Specific T Cells for Immunotherapy After Allogeneic Stem Cell Transplantation CTL-ADV
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Generation of Clinical Grade Adenovirus Specific T Cells for Adoptive Immunotherapy After Allogeneic Stem Cell Transplantation Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CTL-ADV
Brief Summary:
Fourteen patients will be included for infusion of adenovirus-specific T-cells generated by a clinical grade IFN-γ based immunomagnetic isolation from a leukapheresis from their original donor or a haploidentical donor in case of Umbilical cord blood transplantation in the event of refractory ADV infection or disease
Detailed Description:
Allogeneic Hematopoietic Stem Cell Transplantation HSCT has improved over the last decades However after HSCT and especially with matched unrelated cord blood or haploidentical donors patients often experience a deep immunodeficiency increasing susceptibility to viral infections Among them adenovirus ADV systemic infection often refractory to antiviral treatment is associated with a high mortality rate up to 50 even more in children Viremia monitoring after HSCT has contributed to improve survival allowing the implementation of a pre-emptive anti-viral treatment before any appearance of clinical signs of ADV disease Nevertheless no anti-viral drug is authorized for ADV infections although intravenous IV cidofovir seemed to be up to now the most efficient However nephrotoxicity especially tubular dysfunction is often described requiring hydratation and uroprotection with probenecid and limiting the treatment period
Meanwhile adoptive transfer of ADV-specific T cells prepared with an immunomagnetic clinical grade technology is becoming an alternative treatment that has already proved feasible safe and helpful in viral clearance and immune reconstitution related to an in vivo expansion of ADV-specific T cells leading to clinical improvement Feuchtinger et al 2006 2015 Qazim et al 2013 Our team proposes a multicenter Phase III clinical trial with ADV-specific T cells where 14 patients with refractory ADV infection or disease after unrelated Peripheral blood or umbilical cord blood HSCT are included
Meanwhile adoptive transfer of ADV-specific T cells prepared with an immunomagnetic clinical grade technology is becoming an alternative treatment that has already proved feasible safe and helpful in viral clearance and immune reconstitution related to an in vivo expansion of ADV-specific T cells leading to clinical improvement Feuchtinger et al 2006 2015 Qazim et al 2013 Our team proposes a multicenter Phase III clinical trial with ADV-specific T cells where 14 patients with refractory ADV infection or disease after unrelated Peripheral blood or umbilical cord blood HSCT are included
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None