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Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas (CIVIC)

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ClinicalTrials.gov Identifier: NCT02763254
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Lymphoma, Large B-Cell, Diffuse Post-transplant Lymphoproliferative Disorder Biological: CMD-003 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CMD-003
Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.
Biological: CMD-003
Autologous EBV-specific T cells


Outcome Measures

Primary Outcome Measures :
  1. Best Overall Response [ Time Frame: 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 :
  1. Complete Response Rate [ Time Frame: 3, 6, 9 & 12 months ]
  2. Duration of Response [ Time Frame: 1 year ]
  3. Disease Control [ Time Frame: 3, 6, 9 & 12 months ]
    Percentage of evaluable patients who achieve a complete response (CR), partial response (PR) or stable disease (SD) per Lugano 2014 Disease Response Criteria.

  4. Time to Response [ Time Frame: 1 year ]
  5. Progression Free Survival [ Time Frame: 1 year ]
  6. Disease Free Survival [ Time Frame: 2 years ]
  7. Overall Survival [ Time Frame: 2 years ]
  8. Adverse Events [ Time Frame: 1 year ]

Other Outcome Measures:
  1. EBV DNA Viral Load [ Time Frame: 1 year ]
    Surrogate - Virological response based on reduction in circulating EBV DNA in whole blood and plasma, as measured by polymerase chain reaction (PCR)

  2. ORR based on LYRIC [ Time Frame: 1 year ]
    As assessed by independent radiology committee

  3. EBV antigen specific T cell activity [ Time Frame: 1 year ]
    MoA - as assessed by ELISpot


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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/µL
  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 does 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
  9. Prior allogeneic hematopoietic stem cell transplantation (allo HSCT)
  10. Known history of primary immunodeficiency
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763254


Contacts
Contact: Shannon Inman 832-581-4474 shannon.inman@cellmedica.co.uk

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Rosemarie Abary    626-218-8087    rabary@coh.org   
Principal Investigator: Elizabeth Budde, MD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Maria Fernanda Fortiz    202-476-4225    MFFORTIZ@childrensnational.org   
Principal Investigator: Catherine Bollard, MD         
United States, Maryland
John Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Stephanie Watkins, RN, BSN    410-502-6058    swatki30@jhmi.edu   
Principal Investigator: Richard Ambinder, MD         
United States, Massachusetts
Massachusetts General Not yet recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Jeffrey Barnes, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Yi Lin, MD         
United States, New York
New York-Presbyterian/Weill Cornell Recruiting
New York, New York, United States, 10065
Principal Investigator: Jia Ruan, MD         
United States, Pennsylvania
Univ of Pittsburgh - Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Carrie McEvoy    412-623-3083    mcevoycb@upmc.edu   
Principal Investigator: Jing-Zhou Hou, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Vicky Torrano    832-824-7821    vxtorran@txch.org   
Principal Investigator: Helen Heslop, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Linda Claret    713-792-1044    LCClaret@mdanderson.org   
Principal Investigator: Yasushiro Oki, MD         
Sponsors and Collaborators
Cell Medica Ltd
Investigators
Study Director: Kurt Gunter, MD Cell Medica, Inc
More Information

Responsible Party: Cell Medica Ltd
ClinicalTrials.gov Identifier: NCT02763254     History of Changes
Other Study ID Numbers: CM-2015-01
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cell Medica Ltd:
Epstein-Barr Virus
DLBCL
PTLD
EBV
CIVIC
HL
T cell

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Lymphoproliferative Disorders
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin