Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391814
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-22
Brief Title:
Donor-Derived EBV-Specific T Cells for Life Threatening EBV-lymphoma OLIP-EBV-TCL-01-HMR01
Sponsor:
Ciusss de LEst de lÎle de Montréal
Organization:
Ciusss de LEst de lÎle de Montréal
Study Overview
Official Title:
Open-Label Individual Patient Study of Epstein-Barr Virus EBV Specific T-Cell Lines for the Treatment of a Lymphoproliferative Disease and Hemophagocytic Syndrome Associated With EBV
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
Single-patient trial aiming to provide immunological consolidation following allogeneic stem cell transplantation to a young adult patient suffering from a systemic EBV-positive lymphoma of childhood
Detailed Description:
Following a presumed primary EBV infection a 19 year old female patient rapidly suffered systemic inflammatory response hemophagocytosis multi-organ failure and evidence of EBV T-cell lymphoma
The patient was aggressively treated and responded to SMILE-based chemotherapy Once complete response was ascertained by PET imaging the patient underwent myeloablative HLA-matched unrelated allogeneic stem cell transplantation cyclophosphamide 60mgKg total body irradiation - 12Gy with anti-thymocyte globulin The stem cell donor had a positive serology for EBV IgG
The patients EBV titer was weakly positive at the time of transplantation A decision was made to offer consolidative treatment consisting of donor-derived ex vivo expanded EBV-reactive T cells following transplantation
A EBV-specific T-cell line was manufactured from a portion of the cryopreserved G-CSF mobilized peripheral graft after appropriate authorizations were obtained
The patient suffered a severe episode of intestinal graft-versus-host disease early following transplantation but received a first dose of EBV-reactive T cells 20x10e6 T cellsmeter square of body surface area 5 months post-transplantation
The patient was aggressively treated and responded to SMILE-based chemotherapy Once complete response was ascertained by PET imaging the patient underwent myeloablative HLA-matched unrelated allogeneic stem cell transplantation cyclophosphamide 60mgKg total body irradiation - 12Gy with anti-thymocyte globulin The stem cell donor had a positive serology for EBV IgG
The patients EBV titer was weakly positive at the time of transplantation A decision was made to offer consolidative treatment consisting of donor-derived ex vivo expanded EBV-reactive T cells following transplantation
A EBV-specific T-cell line was manufactured from a portion of the cryopreserved G-CSF mobilized peripheral graft after appropriate authorizations were obtained
The patient suffered a severe episode of intestinal graft-versus-host disease early following transplantation but received a first dose of EBV-reactive T cells 20x10e6 T cellsmeter square of body surface area 5 months post-transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None