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 transplantion. - STP-LYM-01-V01

Medizinische Fakultaet der Technischen Universitaet Muenchen0 sitesJuly 22, 2009

Overview

No summary available.

Registry

who.int

Start Date

July 22, 2009

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Medizinische Fakultaet der Technischen Universitaet Muenchen

•\- 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);
•\- Patients with relapsed / refractory disease that survived at least 60 days after allogeneic transplantation;
•\- Eastern Cooperative Oncology Group (ECOG) performance status \> 2
•\- 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)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•\- 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;
•\- Any condition which in the judgement of the Investigator would place the subject at undue risk or interfere with the results of the study.