A PHASE I/II CLINICAL TRIAL EVALUATING DCVax-Direct, AUTOLOGOUS ACTIVATED DENDRITIC CELLS FOR INTRATUMORAL INJECTION, IN PATIENTS WITH SOLID TUMORS
Inclusion Criteria (summary):
- Age between 18 and 75 years (inclusive) at screening.
- Karnofsky performance status (KPS) of 60 or higher or Eastern Cooperative Oncology
Group (ECOG) 0-2 at screening.
- Patients with a histological or cytopathological confirmed diagnosis of a locally
advanced or metastatic solid tumor malignancy for which standard treatment is no
longer effective or does not offer curative or life-prolonging potential per
- Not eligible for complete resection due to either, tumor location, physician's
assessment or patient's choice.
- Must have completed at least one and no more than four treatment regimens in the
metastatic or advanced setting in the disease currently under treatment to reduce
tumor burden. Treatment must have been discontinued at least 14 days prior to
- Any steroid therapy >2 mg dexamethasone or equivalent dose should be stopped or have
been tapered down 2 weeks prior to the leukapheresis.
- At least one measurable tumor mass, i.e. a lesion that can accurately be measured by
CT/MRI in at least one dimension with longest diameter ≥ 1 cm, that is accessible for
injection either with or without imaging (CT/ultrasound) guidance.
- Adequate hematological, hepatic, and renal function,
- Adequate blood coagulation parameters
- Life expectation of >3 months.
Exclusion Criteria (Summary):
- Positive HIV-1, HIV-2, or Human T-lymphotropic virus (HTLV-I/II) tests.
- History of current or prior (within the last two years) active clinically significant
malignancy other than the tumor type for which DCVax-Direct treatment is considered ,
and except for adequately treated basal cell or squamous cell skin cancer or in situ
- Presence of brain metastases, unless treated surgically and/or irradiated and
clinically stable off steroids or on low dose (< 2 mg per day) steroids for ≥ 14
days, or presence of leptomeningeal disease.
- History of immunodeficiency or unresolved autoimmune disease.
- Requirement for ongoing immunosuppressants.
- Prior active immunotherapy for cancer within the past 2 years.
- Ongoing medical need for continuous anti-coagulation or anti-platelet medication.
- Known genetic cancer-susceptibility syndromes.
- Acute or active uncontrolled infection
- Ongoing fever ≥ 101.5 degrees F/38.6 degrees C at screening.
- Unstable or severe intercurrent medical conditions such as unstable angina,
uncontrolled arrhythmias, Crohn's Disease, ulcerative colitis etc.
- Females of child-bearing potential who are pregnant or lactating or who are not using
adequate contraception (surgical, hormonal or double barrier, i.e. condom and
- Allergy or anaphylaxis to any of the reagents used in this study.
- Inability to obtain informed consent because of psychiatric or complicating medical
- Inability or unwillingness to return for required visits and follow-up exams.