Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma

NCT01948180 | Terminated Phase 2 DMC

• 1 other identifier: CM-2013-01
• Study Type: interventional
• Target: 15
• Locations: 4 countries
• Sites: 11

Brief Summary

To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma

Conditions

Lymphoma, Extranodal NK-T-Cell; EBV

Keywords

NKTCL; T cell; CITADEL; Epstein-Barr Virus; Natural Killer

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Defined as best observed response (complete response or partial response) per Lugano 2014 Disease Response Criteria.

  1 year

Secondary Outcomes (7)

• Complete Response Rate

  1 year

• Response Duration

  2 years

• Time to Response

  1 year

• Progression Free Survival

  2 years

• Disease Free Survival

  2 years

Other Outcomes (2)

• Immunological assessment of EBV-specific T-cell activity and phenotyping

  1 year

• Monitor levels of plasma and whole blood EBV DNA (viral load)

  1 year

Study Arms (1)

baltaleucel-T

EXPERIMENTAL

Treatment consists of 2 infusions of 2x10E7 cells/m2 given on Days 1 and 15 intravenously via a peripheral or central line over a 1 to 10 minute period. Subjects who tolerate the study treatment well and who do not require treatment with an alternative chemotherapeutic agent will be eligible for up to 3 additional infusions of 2x10E7 cells/m2 administered at week 8, month 3 and month 6.

Biological: baltaleucel-T

Interventions

baltaleucel-T BIOLOGICAL

Autologous EBV-specific T-cells

Also known as: CMD-003

baltaleucel-T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of extranodal NK/T lymphoma, per WHO classification, 4th ed., which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1 immunostaining.
• a) Active Disease
• (1) Clinically suspected or documented relapse/progression, in first or second relapse following at least one cycle of an asparaginase-based chemotherapy regimen OR (2) Initial disease or first or second relapse and unable to tolerate one full cycle of asparaginase-based chemotherapy regimen OR b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotherapy.
• \. Male or female ≥ 18 years of age. 4. Weigh ≥ 35 kg. 5. ECOG performance score 0-2, inclusively. 6. Negative β-hCG test in women of childbearing potential. 7. Able to understand and comply with the requirements of the study and to provide written informed consent.

You may not qualify if:

• CNS lymphoma.
• NK cell leukemia.
• Hemophagocytic lymphohistiocytosis.
• Positive for HIV, hepatitis B, hepatitis C, syphilis or human T Cell leukemia virus (HTLV).
• Use of systemic corticosteroids \>0.5 mg/kg/day within 10 days prior to obtaining 200 mL whole blood starting material.
• Patient is pregnant or lactating.
• Active second malignancy.
• Any prior allogeneic hematopoietic stem cell or solid organ transplant.
• Asparaginase refractory disease, defined by any one of the following:
• Progression at any time during initial asparaginase based chemotherapy and up to 3 months after end of initial asparaginase based chemotherapy, OR
• Failure to achieve at least PR with initial asparaginase based chemotherapy.
• Absolute lymphocyte count (ALC) \<400/µL.
• Any previous autologous EBV specific T cell treatment.
• Systemic fungal, bacterial, viral or other infection that is not controlled.
• Third or greater relapse.

Sponsors & Collaborators

• Cell Medica Ltd: lead

Study Sites (11)

Dana-Farber Cancer Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Universitaire Ouest

Paris, 75015, France

Location

Centre Hospitalier de Lyon

Pierre-Bénite, 69310, France

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Cancer Center

Seoul, 138-736, South Korea

Location

University College London Hospital

London, UK, NW1 2PG, United Kingdom

Location

The Christie Clinic

Manchester, UK, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell; Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Helen Heslop, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Kurt Gunter, MD

  Cell Medica

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 23, 2013
• Study Start: September 1, 2014
• Primary Completion: April 16, 2018
• Study Completion: September 7, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); KR (2); FR (2); GB (2)