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CITADEL: Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma

Sponsor
Cell Medica Ltd (Industry)
Overall Status
Terminated
CT.gov ID
NCT01948180
Collaborator
(none)
15
Enrollment
11
Locations
1
Arm
48.2
Actual Duration (Months)
1.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: baltaleucel-T
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Apr 16, 2018
Actual Study Completion Date :
Sep 7, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: baltaleucel-T

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
Autologous EBV-specific T-cells
Other Names:
  • CMD-003

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate [1 year]

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

    Secondary Outcome Measures

    1. Complete Response Rate [1 year]

    2. Response Duration [2 years]

    3. Time to Response [1 year]

    4. Progression Free Survival [2 years]

    5. Disease Free Survival [2 years]

    6. Overall Survival [2 years]

    7. Adverse Events [1 year]

    Other Outcome Measures

    1. Immunological assessment of EBV-specific T-cell activity and phenotyping [1 year]

    2. Monitor levels of plasma and whole blood EBV DNA (viral load) [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    FOR SCREENING PHASE:
    Inclusion Criteria:

    1. 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.

      1. 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.

    1. 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.
    Exclusion Criteria:

    1. CNS lymphoma.

    2. NK cell leukemia.

    3. Hemophagocytic lymphohistiocytosis.

    4. Positive for HIV, hepatitis B, hepatitis C, syphilis or human T Cell leukemia virus (HTLV).

    5. Use of systemic corticosteroids >0.5 mg/kg/day within 10 days prior to obtaining 200 mL whole blood starting material.

    6. Patient is pregnant or lactating.

    7. Active second malignancy.

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

    9. Asparaginase refractory disease, defined by any one of the following:

    10. Progression at any time during initial asparaginase based chemotherapy and up to 3 months after end of initial asparaginase based chemotherapy, OR

    11. Failure to achieve at least PR with initial asparaginase based chemotherapy.

    12. Absolute lymphocyte count (ALC) <400/µL.

    13. Any previous autologous EBV specific T cell treatment.

    14. Systemic fungal, bacterial, viral or other infection that is not controlled.

    15. Third or greater relapse.

    FOR TREATMENT PHASE:
    Inclusion Criteria:

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

    2. Active disease based on any one of the following present at the baseline study visit or within two weeks prior to the baseline study visit:

    3. Imaging (may use local imaging)

    4. Clinical sign(s) including skin lesions consistent with lymphoma, organ dysfunction or organomegaly not attributable to other causes; or other clinical sign(s)

    5. Detectable blood or plasma ENV DNA (may use local laboratory)

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

    7. Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities as defined by ≤ Grade 1 according to NCI CTCAE v4.0.

    8. Life expectancy ≥ 8 weeks.

    Exclusion Criteria:

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

    2. Radiotherapy within prior 3 weeks.

    3. Major surgery within prior 2 weeks.

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

    5. Evidence of hepatic dysfunction based on serum total bilirubin >3 times upper limit of normal (ULN), or ALT >5 times ULN or AST >5 times ULN.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dana-Farber Cancer Center Boston Massachusetts United States 02215
    2 Mayo Clinic Rochester Minnesota United States 55905
    3 The Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    4 Baylor College of Medicine Houston Texas United States 77030
    5 MD Anderson Cancer Center Houston Texas United States 77030
    6 Universitaire Ouest Paris France 75015
    7 Centre Hospitalier de Lyon Pierre Bénite France 69310
    8 Samsung Medical Center Seoul Korea, Republic of 135-710
    9 Asan Cancer Center Seoul Korea, Republic of 138-736
    10 University College London Hospital London UK United Kingdom NW1 2PG
    11 The Christie Clinic Manchester UK United Kingdom M20 4BX

    Sponsors and Collaborators

    • Cell Medica Ltd

    Investigators

    • Principal Investigator: Helen Heslop, MD, Baylor College of Medicine
    • Study Director: Kurt Gunter, MD, Cell Medica

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cell Medica Ltd
    ClinicalTrials.gov Identifier:
    NCT01948180
    Other Study ID Numbers:
    • CM-2013-01
    First Posted:
    Sep 23, 2013
    Last Update Posted:
    Mar 13, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Cell Medica Ltd
    NKTCL
    T cell
    CITADEL
    Epstein-Barr Virus
    Natural Killer
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Extranodal NK-T-Cell

    Study Results

    No Results Posted as of Mar 13, 2019