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
To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma
Terminated
Phase 2
NCT ID: NCT01948180
ORG ID: CM-2013-01
Lymphoma, Extranodal NK-T-Cell
EBV
Drug | Synonyms | Arms |
---|
To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients
with aggressive EBV positive extranodal NK/T-cell lymphoma
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. |
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
Assess overall response rate (ORR = CR + PR)
Response duration
Overall survival