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Trial Title:
Donor-Derived EBV-Specific T Cells for Life Threatening EBV-lymphoma (OLIP-EBV-TCL-01-HMR01)
NCT ID:
NCT06391814
Condition:
EBV Associated Lymphoma
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
Adoptive immunotherapy
EBV
Systemic EBV-positive T-cell lymphoma of childhood
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
single patient
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
EBV-specific T cells
Description:
Consolidative cellular immunotherapy consisting of one (or up to 4) infusion of ex vivo
expanded T cells
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 60mg/Kg,
total body irradiation - 12Gy with anti-thymocyte globulin). The stem cell donor had a
positive serology for EBV (IgG).
The patient's 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
cells/meter square of body surface area 5 months post-transplantation
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Capacity to provide informed consent
2. Age ≥ 18
3. Negative serum pregnancy test and use of effective contraception method.
Exclusion Criteria:
1. Administration within less than 28 days of T-cell depleting antibodies (ATG, OKT3,
Campath)
2. Pregnancy
3. Any abnormal condition or laboratory result that is considered by the Principal
Investigator capable of altering patient or study outcome.
4. Active uncontrolled GVHD (acute GVHD grade II-IV or progressive extensive chronic
GVHD) at time of enrolment or infusion.
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ciusss-Emtl
Address:
City:
Montréal
Zip:
H1T 2M4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Jean-Sébastien Delisle, MD, PhD
Phone:
514-252-3400
Phone ext:
6381
Email:
js.delisle@umontreal.ca
Start date:
January 16, 2024
Completion date:
April 5, 2025
Lead sponsor:
Agency:
Ciusss de L'Est de l'Île de Montréal
Agency class:
Other
Source:
Ciusss de L'Est de l'Île de Montréal
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06391814
