Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma

Stopped early · Phase 2

Conditions studied: Lymphoma, Extranodal NK-T-Cell, EBV

In brief

To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma

Key facts

Study ID

NCT01948180

Run by

Cell Medica Ltd

People needed

15

Starts

2014-09-01

Expected to finish

2018-09-07

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of extranodal NK/T lymphoma, per WHO classification, 4th ed., which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1 immunostaining.
• a) Active Disease
• (1) Clinically suspected or documented relapse/progression, in first or second relapse following at least one cycle of an asparaginase-based chemotherapy regimen OR (2) Initial disease or first or second relapse and unable to tolerate one full cycle of asparaginase-based chemotherapy regimen OR b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotherapy.
• Male or female ≥ 18 years of age. 4. Weigh ≥ 35 kg. 5. ECOG performance score 0-2, inclusively. 6. Negative β-hCG test in women of childbearing potential. 7. Able to understand and comply with the requirements of the study and to provide written informed consent.

You may not qualify if…

• CNS lymphoma.
• NK cell leukemia.
• Hemophagocytic lymphohistiocytosis.
• Positive for HIV, hepatitis B, hepatitis C, syphilis or human T Cell leukemia virus (HTLV).
• Use of systemic corticosteroids >0.5 mg/kg/day within 10 days prior to obtaining 200 mL whole blood starting material.
• Patient is pregnant or lactating.
• Active second malignancy.
• Any prior allogeneic hematopoietic stem cell or solid organ transplant.
• Asparaginase refractory disease, defined by any one of the following:
• Progression at any time during initial asparaginase based chemotherapy and up to 3 months after end of initial asparaginase based chemotherapy, OR
• Failure to achieve at least PR with initial asparaginase based chemotherapy.
• Absolute lymphocyte count (ALC) <400/µL.
• Any previous autologous EBV specific T cell treatment.
• Systemic fungal, bacterial, viral or other infection that is not controlled.
• Third or greater relapse.
• FOR TREATMENT PHASE:
• Inclusion Criteria:
• Documented relapse or progression following at least one prior cycle of an asparaginase-containing chemotherapy regimen.
• Active disease based on any one of the following present at the baseline study visit or within two weeks prior to the baseline study visit:
• Imaging (may use local imaging)
• Clinical sign(s) including skin lesions consistent with lymphoma, organ dysfunction or organomegaly not attributable to other causes; or other clinical sign(s)
• Detectable blood or plasma ENV DNA (may use local laboratory)
• Completed most recent course of chemotherapy at least 2 weeks prior to first study drug dose.
• Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities as defined by ≤ Grade 1 according to NCI CTCAE v4.0.
• Life expectancy ≥ 8 weeks.

Where it is running

• Dana-Farber Cancer Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Universitaire Ouest — Paris, France
• Centre Hospitalier de Lyon — Pierre-Bénite, France
• Samsung Medical Center — Seoul, South Korea
• Asan Cancer Center — Seoul, South Korea
• University College London Hospital — London, UK, United Kingdom
• The Christie Clinic — Manchester, UK, United Kingdom

Full record on ClinicalTrials.gov

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