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

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an investigator driven, open-label, non-randomized, uncontrolled, dose escalating Phase I/II study evaluating the safety and preliminary efficacy of the trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI) for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade non-Hodgkin´s lymphoma after allogeneic transplantation

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität München
• Treatments: Antibodies

Criteria

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