Clinical Trials /

Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas

NCT02763254

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Hodgkin Lymphoma
  • Post-Transplant Lymphoproliferative Disorder
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Cellular Immunotherapy for Viral Induced Cancer

Title

  • Brief Title: Cellular Immunotherapy for Viral Induced Cancer
  • Official Title: A Phase 2 Open Label Study to Investigate the Safety and Clinical Activity of Autologous EBV-specific T Cells (CMD-003) for the Treatment of Patients With EBV Positive Lymphomas
  • Clinical Trial IDs

    NCT ID: NCT02763254

    ORG ID: CM-2015-01

    Trial Conditions

    Hodgkin Lymphoma

    Lymphoma, Large B-Cell, Diffuse

    Post-transplant Lymphoproliferative Disorder

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    CMD-003 Experimental Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously on day 1, day 15, month 2, month 3, and month 6.

    Eligibility Criteria

    Inclusion Criteria:

    1. 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.

    2. Presence of active lymphoma or active PTLD, based on imaging performed within the
    previous 3 months.

    3. Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.

    4. Absolute lymphocyte count (ALC) >500/L

    5. Male or female 12 years of age

    6. Weight 35 kg

    7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or
    Lansky score 60, as age appropriate

    8. 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:

    1. Known central nervous system (CNS) lymphoma

    2. Primary refractory HL or DLBCL

    3. Bulky disease

    4. Relapse or progression following previous autologous EBV specific T cell treatment.

    5. Use of systemic corticosteroids >0.5 mg/kg/day prednisolone or equivalent dose of
    alternative corticosteroid within 10 days prior to obtaining 200 mL starting
    material.

    6. Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus
    (HTLV)

    7. Patient is pregnant or lactating

    8. Systemic fungal, bacterial, viral or other infection that is not controlled

    Minimum Eligible Age: 12 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Best Overall Response

    Secondary Outcome Measures

    Complete Response Rate

    Duration of Response

    Clinical benefit

    Time to Response

    Progression Free Survival

    Overall Survival

    Trial Keywords

    Epstein-Barr Virus (EBV)