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

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ClinicalTrials.gov Identifier: NCT02763254
Recruitment Status : Terminated (Insufficient recruitment rate)
First Posted : May 5, 2016
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Cell Medica Ltd

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 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
Actual Primary Completion Date : February 17, 2018
Actual Study Completion Date : February 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




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



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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

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


Locations
United States, California
City of Hope
Duarte, California, United States, 91010
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Maryland
John Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
New York-Presbyterian/Weill Cornell
New York, New York, United States, 10065
United States, Pennsylvania
Univ of Pittsburgh - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cell Medica Ltd
Investigators
Study Director: Kurt Gunter, MD Cell Medica, Inc

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: January 14, 2019
Last Verified: January 2019
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