Donor-Derived EBV-Specific T Cells for Life Threatening EBV-lymphoma (OLIP-EBV-TCL-01-HMR01)
NCT ID: NCT06391814
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1 participants
INTERVENTIONAL
2024-01-16
2025-04-05
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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EBV-specific T cells
Consolidative cellular immunotherapy consisting of one (or up to 4) infusion of ex vivo expanded T cells
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18
3. Negative serum pregnancy test and use of effective contraception method.
Exclusion Criteria
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.
FEMALE
No
Sponsors
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Ciusss de L'Est de l'Île de Montréal
OTHER
Responsible Party
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Locations
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Ciusss-Emtl
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Jean-Sébastien Delisle, MD, PhD
Role: primary
Other Identifiers
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2024-3579
Identifier Type: -
Identifier Source: org_study_id