Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas

Phase 2

Terminated

Conditions: Hodgkin Lymphoma
Post-transplant Lymphoproliferative Disorder
Lymphoma, Large B-Cell, Diffuse

Brief Summary: To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.

Recruitment & Eligibility

Inclusion Criteria

The study will include three primary cohorts, with any of the following EBV+ diseases:

Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy OR 2) relapse following autologous transplantation.

Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.

Cohort C - PTLD, rituximab treatment failure.
Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.
Absolute lymphocyte count (ALC) >500/µL
Male or female ≥ 12 years of age
Weight ≥ 35 kg
Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate
Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients.

Exclusion Criteria

Known central nervous system (CNS) lymphoma
Primary refractory HL or DLBCL
Bulky disease
Relapse or progression following previous autologous EBV specific T cell treatment.
Use of systemic corticosteroids > 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material
Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus (HTLV).
Patient is pregnant or lactating
Systemic fungal, bacterial, viral or other infection that is not controlled
Prior allogeneic hematopoietic stem cell transplantation (allo HSCT)
Known history of primary immunodeficiency

Arm && Interventions

Group	Intervention	Description
baltaleucel-T	baltaleucel-T	Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.

Primary Outcome Measures

Name	Time	Method
Best Overall Response	1 year	Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 year	Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration.