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

Leukemia Clinical Trial

— STP-LYM-01  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01138579
• Other study ID #: STP-LYM-01-V01
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: August 2010
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Stem Cell Transplantation

Intervention

Drug:
• FBTA05

Locations

Country	Name	City	State
Germany	3. Medizinische Klinik, Klinikum rechts der Isar der TU München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Determination of the maximum tolerated dose (MTD)
Primary	Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI