Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas

Hodgkin Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02763254
• Other study ID #: CM-2015-01
• Status: Terminated
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: February 17, 2018

Study information

• Verified date: March 2019
• Source: Cell Medica Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 17, 2018
• Est. primary completion date: February 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• baltaleucel-T
Autologous EBV-specific T cells

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cell Medica Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year