Study of the Trifunctional Antibody FBTA05 and Donor Lymphocyte Infusion in B-cell Lymphoma After Allogeneic Stem Cell Transplantation (STP-LYM-01)

Inclusion Criteria:

• Patient´s written informed consent
• ≥ 18 years of age; male and female
• Confirmed CLL, low grade NHL or high grade NHL on standard histological or immunophenotypical criteria described in the WHO classification of lymphoid malignancies
• CD20 positivity (if not already confirmed)
• Adequate haematological, liver and kidney functions
• Platelet count ≥25,000mm³ (=25 x 10^9/l)
• Patients with active disease (relapsed/refractory) that survived at least 60 days after allogeneic transplantation
• Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Appendix IV)
• Negative pregnancy test (no more than 2 days before enrolment) and adequate contraception during the study in women of child bearing potential (pre- menopausal, <2 years post-menopausal or not surgically sterile)

Exclusion Criteria:

• Any anti-CD20 and / or any other anti-T cell directed antibody treatments < 3 months before application of FBTA05
• Positivity for human anti-mouse antibodies (HAMAs)
• History of GvHD ° III or IV, or GvHD requiring steroid therapy with more than 10 mg/day
• Known or suspected hypersensitivity to recombinant, murine or rat proteins
• AST/SGOT greater than 10 x ULN (grade 3, CTCAE)
• Bilirubin greater than 5 x ULN (grade 3, CTCAE)
• Creatinine greater than 3.5 mg/dl (grade 3, CTCAE)
• Acute or uncontrolled chronic infections, viral infections at risk of reactivation (e.g.HCV, HBV, HIV)
• Unable or unwilling to comply fully with the protocol
• Any condition which in the judgement of the Investigator would place the subject at undue risk or interfere with the results of the study