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

Technical University of Munich

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Stem Cell Transplantation

Leukemia

Treatments

Drug: FBTA05

Study type

Interventional

Funder types

Other

Identifiers

NCT01138579

STP-LYM-01-V01

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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