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

Cell Medica

Status and phase: Terminated; Phase 2

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

Treatments: Biological: baltaleucel-T

Study type: Interventional

Funder types: Industry

Identifiers

NCT02763254

CM-2015-01

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 12+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

baltaleucel-T

Experimental group

Description:

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

Treatment:

Biological: baltaleucel-T