Phase I/II Dose-escalation Study of the Investigational Trifunctional Bispecific Anti-CD20 x Anti-CD3 Antibody FBTA05 in Combination With Donor Lymphocyte Infusion (DLI) in Patients With CD20 Positive Chronic Lymphocytic Leukemia (CLL), Low and High Grade Non-Hodgkin´s Lymphoma (NHL) After Allogeneic Stem Cell Transplantation
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