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.
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
Drug | Synonyms | Arms |
---|
baltaleucel-T | | baltaleucel-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
Name | Type | Description | Interventions |
---|
baltaleucel-T | Experimental | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. | |
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