RBL001/RBL002 Phase I Clinical Trial

Exclusion Criteria

• •Antigen expression confirmed by RT-PCR analysis from FFPE
• •≥ 18 years of age
• •Written informed consent (part I and part II)
• •ECOG performance status (PS) 0-1 or Karnofsky Index 70-100 %
• •Life expectancy \> 3 months
• •WBC ≥ 3x109/L
• •Hemoglobin ≥ 10 g/dl
• •Platelet count ≥ 100,000/mm³
• •LDH level \< 2.0 x ULN
• •Negative pregnancy test (measured by β-HCG) for females of childbearing age
• •Suitable lymph nodes for injection using ultrasound guidance
• •Pregnancy or breastfeeding
• •Primary ocular melanoma
• •Presence of history (\< 5 years) of a second malignancy other than squamous or basal cell carcinoma, non-active prostate cancer or cervical carcinoma in situ
• •Brain metastases
• •Known or symptomatic pleural effusions and/or ascites
• •Known hypersensitivity to the active substance or to any of the excipients
• •A serious local infection (e. g. cellulitis, abscess) or systemic infection (e. g. pneumonia, septicemia) which requires systemic antibiotic treatment within 2 weeks prior to the first dose of study medication
• •Acute or chronic active hepatitis B or C infection, EBV or CMV
• •Receipt of allogenic stem cell transplantation
• •Clinically relevant autoimmune disease
• •Systemic immune suppression:
• •HIV disease
• •Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted) Other clinical relevant systemic immune suppression
• •Symptomatic congestive heart failure (NYHA 3 or 4)
• •Unstable angina pectoris
• •Radiotherapy, chemotherapy, major surgery, immunotherapy, vaccination, any other concurrent anticancer therapy or any investigational drug within 28 days before the first treatment of this study
• •Minor surgery within 14 days before the first treatment of this study
• •Treatment with Ipilimumab within 84 days before the first treatment of this study
• •Fertile males and females who are unwilling to employ adequate means of contraception (e. g. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches or intrauterine device) during study treatment and 28 days after the last dose of study treatment
• •Presence of a serious concurrent illness or other condition (e. g. psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol