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

Conditions: CD20 positive chronic lymphocytic leukemia (CLL)low and high grade non-Hodgkin´s lymphoma (NHL)

Registration Number: EUCTR2009-014641-88-DE

Lead Sponsor: Medizinische Fakultaet der Technischen Universitaet Muenchen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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);
- 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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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