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

Title

  • Brief Title: Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
  • 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

  • ORG STUDY ID: CM-2015-01
  • NCT ID: NCT02763254

Conditions

  • Hodgkin Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Post-transplant Lymphoproliferative Disorder

Interventions

DrugSynonymsArms
baltaleucel-Tbaltaleucel-T

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.

Trial Arms

NameTypeDescriptionInterventions
baltaleucel-TExperimentalTreatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.
  • baltaleucel-T

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/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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Best Overall Response
Time Frame:1 year
Safety Issue:
Description: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

Measure:Adverse Events
Time Frame:1 year
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Cell Medica Ltd

Trial Keywords

  • Epstein-Barr Virus
  • DLBCL
  • PTLD
  • EBV
  • CIVIC
  • HL
  • T cell

Last Updated

March 26, 2019