Clinical Trials /

Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma

NCT01948180

Description:

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

Related Conditions:
  • Mature T-Cell and NK-Cell Lymphoma/Leukemia
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Cellular <span class="go-doc-concept go-doc-intervention">Immunotherapy</span> Treatment Antigen-Directed for EBV Lymphoma

Title

  • Brief Title: Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma
  • Official Title: A Phase 2 Single Arm Study to Investigate the Efficacy of Autologous EBV-specific T-cells for the Treatment of Patients With Aggressive EBV Positive Extranodal NK/T-cell Lymphoma (ENKTCL)
  • Clinical Trial IDs

    NCT ID: NCT01948180

    ORG ID: CM-2013-01

    Trial Conditions

    Lymphoma, Extranodal NK-T-Cell

    EBV

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

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

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    CMD-003 Experimental Treatment consists of two injections 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 without clinical signs of disease progression at the week 8 assessment will be eligible for up to 3 additional injections of 2x10E7 cells/m2 administered at week 8, month 3 and month 6.

    Eligibility Criteria

    FOR SCREENING PHASE:

    Inclusion Criteria:

    1. Diagnosis of extranodal NK/T lymphoma, perWHO classification, 4th ed., which must
    include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1
    immunostaining.

    2. a) Clinically suspected or documented relapse/progression, at any time following at
    least one cycle of an asparaginase-based chemotherapy OR b) High-risk disease (stage
    III/IV, KPI groups 3-4 or IPI intermediate-high) at any time (regardless of
    chemotherapy status and disease relapse/ progression)

    3. Male or female 18 years of age.

    4. Weigh 35 kg.

    5. ECOG performance score 0-2, inclusively.

    6. Negative -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.

    Exclusion Criteria:

    1. CNS lymphoma.

    2. NK cell leukemia.

    3. Hemophagocytic lymphohistiocytosis.

    4. Positive laboratory test for anti-HIV 1,2; HBsAg, anti-HTLV-I; anti-HCV, or syphilis
    (Patients with anti-hepatitis B core antibody are eligible if negative for HBsAg).

    5. Use of systemic corticosteroids >0.5 mg/kg/day within 10 days prior to obtaining 100
    mL whole blood starting material.

    6. Patient is pregnant or lactating.

    7. Female patient of childbearing potential unwilling to use effective birth control.

    8. Sexually active patients unwilling to utilize one of the more effective birth control
    methods during the study and for 6 months after the study treatment is concluded. The
    male partner should use a condom.

    9. Clinically significant medical condition e.g. pulmonary, neurological,
    cardiovascular, metabolic, that could jeopardize patient safety, interfere with the
    objectives of the protocol, or limit patient compliance with study requirements, as
    determined by the Investigator.

    10. Active second malignancy.

    11. Previous non-hematological malignancy, except for adequately treated basal-cell
    carcinoma of skin or cervical carcinoma in-situ without current evidence of disease,
    unless the tumor was treated with curative intent more than 5 years prior to study
    entry.

    12. Any prior allogeneic hematopoietic stem cell or solid organ transplant.

    FOR TREATMENT PHASE:

    Inclusion Criteria:

    1. All Screening Phase inclusion criteria.

    2. Documented relapse or progression following at least one prior cycle of an
    asparaginase-containing chemotherapy regimen.

    3. At least one prior cycle of gemcitabine-based salvage chemotherapy.

    4. Completed most recent course of chemotherapy at least 2 weeks prior to first study
    drug dose.

    5. Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities
    as defined by

    Grade 1 according to NCI CTCAE v4.0.

    6. Life expectancy 8 weeks.

    7. Pulse oximetry of 90% on room air.

    Exclusion Criteria:

    1. All Screening Phase exclusion criteria.

    2. Use of any investigational agents within prior 4 weeks.

    3. Radiotherapy within prior 3 weeks.

    4. Major surgery within prior 2 weeks.

    5. Systemic corticosteroids within 24 hours prior to study drug administration.

    6. Symptoms of cardiac failure with New York Heart Association classification of III or
    IV.

    7. Clinically significant medical condition e.g. infection, pulmonary, neurological,
    cardiovascular, metabolic, that could jeopardize patient safety, interfere with the
    objectives of the protocol, or limit patient compliance with study requirements, as
    determined by the Investigator.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Assess overall response rate (ORR = CR + PR)

    Secondary Outcome Measures

    Response duration

    Overall survival

    Trial Keywords