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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
baltaleucel-T
Sponsored by
Cell Medica Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Epstein-Barr Virus, DLBCL, PTLD, EBV, CIVIC, HL, T cell

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

baltaleucel-T

Arm Description

Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.

Outcomes

Primary Outcome Measures

Best Overall Response
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

Adverse Events
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.

Full Information

First Posted
April 27, 2016
Last Updated
March 12, 2019
Sponsor
Cell Medica Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02763254
Brief Title
Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
Acronym
CIVIC
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment rate
Study Start Date
November 2016 (undefined)
Primary Completion Date
February 17, 2018 (Actual)
Study Completion Date
February 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cell Medica Ltd

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Lymphoma, Large B-Cell, Diffuse, Post-transplant Lymphoproliferative Disorder
Keywords
Epstein-Barr Virus, DLBCL, PTLD, EBV, CIVIC, HL, T cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
baltaleucel-T
Arm Type
Experimental
Arm Description
Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.
Intervention Type
Biological
Intervention Name(s)
baltaleucel-T
Intervention Description
Autologous EBV-specific T cells
Primary Outcome Measure Information:
Title
Best Overall Response
Description
Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse Events
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months. Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory. Absolute lymphocyte count (ALC) >500/µL Male or female ≥ 12 years of age Weight ≥ 35 kg Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate 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: Known central nervous system (CNS) lymphoma Primary refractory HL or DLBCL Bulky disease Relapse or progression following previous autologous EBV specific T cell treatment. 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 Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus (HTLV). Patient is pregnant or lactating Systemic fungal, bacterial, viral or other infection that is not controlled Prior allogeneic hematopoietic stem cell transplantation (allo HSCT) Known history of primary immunodeficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Gunter, MD
Organizational Affiliation
Cell Medica, Inc
Official's Role
Study Director
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas

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