Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma (CITADEL)
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ClinicalTrials.gov Identifier: NCT01948180 |
Recruitment Status :
Terminated
(Insufficient enrollment rate)
First Posted : September 23, 2013
Last Update Posted : March 13, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma, Extranodal NK-T-Cell EBV | Biological: baltaleucel-T | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | September 2014 |
Actual Primary Completion Date : | April 16, 2018 |
Actual Study Completion Date : | September 7, 2018 |

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 Name: CMD-003 |
- Overall response rate [ Time Frame: 1 year ]Defined as best observed response (complete response or partial response) per Lugano 2014 Disease Response Criteria.
- Complete Response Rate [ Time Frame: 1 year ]
- Response Duration [ Time Frame: 2 years ]
- Time to Response [ Time Frame: 1 year ]
- Progression Free Survival [ Time Frame: 2 years ]
- Disease Free Survival [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 years ]
- Adverse Events [ Time Frame: 1 year ]
- Immunological assessment of EBV-specific T-cell activity and phenotyping [ Time Frame: 1 year ]
- Monitor levels of plasma and whole blood EBV DNA (viral load) [ Time Frame: 1 year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
FOR SCREENING PHASE:
Inclusion Criteria:
- 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.
3. 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:
- 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.
FOR TREATMENT PHASE:
Inclusion Criteria:
- Documented relapse or progression following at least one prior cycle of an asparaginase-containing chemotherapy regimen.
-
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:
- Imaging (may use local imaging)
- Clinical sign(s) including skin lesions consistent with lymphoma, organ dysfunction or organomegaly not attributable to other causes; or other clinical sign(s)
- Detectable blood or plasma ENV DNA (may use local laboratory)
- Completed most recent course of chemotherapy at least 2 weeks prior to first study drug dose.
- Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities as defined by ≤ Grade 1 according to NCI CTCAE v4.0.
- Life expectancy ≥ 8 weeks.
Exclusion Criteria:
- Use of any investigational agents within prior 4 weeks.
- Radiotherapy within prior 3 weeks.
- Major surgery within prior 2 weeks.
- Systemic corticosteroids within 24 hours prior to study drug administration.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948180
United States, Massachusetts | |
Dana-Farber Cancer Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Ohio | |
The Ohio State University Comprehensive Cancer Center | |
Columbus, Ohio, United States, 43210 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
France | |
Universitaire Ouest | |
Paris, France, 75015 | |
Centre Hospitalier de Lyon | |
Pierre Bénite, France, 69310 | |
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 135-710 | |
Asan Cancer Center | |
Seoul, Korea, Republic of, 138-736 | |
United Kingdom | |
University College London Hospital | |
London, UK, United Kingdom, NW1 2PG | |
The Christie Clinic | |
Manchester, UK, United Kingdom, M20 4BX |
Principal Investigator: | Helen Heslop, MD | Baylor College of Medicine | |
Study Director: | Kurt Gunter, MD | Cell Medica |
Responsible Party: | Cell Medica Ltd |
ClinicalTrials.gov Identifier: | NCT01948180 |
Other Study ID Numbers: |
CM-2013-01 |
First Posted: | September 23, 2013 Key Record Dates |
Last Update Posted: | March 13, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
NKTCL T cell CITADEL Epstein-Barr Virus Natural Killer |
Lymphoma Lymphoma, Extranodal NK-T-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell Lymphoma, Non-Hodgkin |