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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02763254
Recruitment Status : Terminated (Insufficient recruitment rate)
First Posted : May 5, 2016
Results First Posted : March 12, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Cell Medica Ltd

Tracking Information
First Submitted Date  ICMJE April 27, 2016
First Posted Date  ICMJE May 5, 2016
Results First Submitted Date  ICMJE February 19, 2019
Results First Posted Date  ICMJE March 12, 2019
Last Update Posted Date March 26, 2019
Study Start Date  ICMJE November 2016
Actual Primary Completion Date February 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
Adverse Events [ Time Frame: 1 year ]
Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • Complete Response Rate [ Time Frame: 8 weeks, 6, 9 & 12 months ]
  • Duration of Response [ Time Frame: 1 year ]
  • Clinical benefit [ Time Frame: 8 weeks, 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.
  • Time to Response [ Time Frame: 1 year ]
  • Progression Free Survival [ Time Frame: 1 year ]
  • Overall Survival [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 3, 2016)
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)
 
Descriptive Information
Brief Title  ICMJE Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hodgkin Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Post-transplant Lymphoproliferative Disorder
Intervention  ICMJE Biological: baltaleucel-T
Autologous EBV-specific T cells
Study Arms  ICMJE Experimental: baltaleucel-T
Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.
Intervention: Biological: baltaleucel-T
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 10, 2019)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2016)
70
Actual Study Completion Date  ICMJE February 17, 2018
Actual Primary Completion Date February 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02763254
Other Study ID Numbers  ICMJE CM-2015-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cell Medica Ltd
Study Sponsor  ICMJE Cell Medica Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kurt Gunter, MD Cell Medica, Inc
PRS Account Cell Medica Ltd
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP