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

March 12, 2019 updated by: Cell Medica Ltd

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cell Medica Ltd

Investigators

  • Study Director: Kurt Gunter, MD, Cell Medica, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

February 17, 2018

Study Completion (Actual)

February 17, 2018

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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