Cellular Immunotherapy for Viral Induced Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-02-17

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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baltaleucel-T

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

Group Type EXPERIMENTAL

baltaleucel-T

Intervention Type BIOLOGICAL

Autologous EBV-specific T cells

Interventions

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baltaleucel-T

Autologous EBV-specific T cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No