Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas

Stopped early · Phase 2

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

In brief

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.

Key facts

Study ID

NCT02763254

Run by

Cell Medica Ltd

People needed

1

Starts

2016-11-01

Expected to finish

2018-02-17

Last updated by the study team

2019-03-26

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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