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

Sponsor

Technische Universität München (Other)

Overall Status

Terminated

CT.gov ID

NCT01138579

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Leukemia Stem Cell Transplantation	Drug: FBTA05	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2010

Anticipated Primary Completion Date :

May 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: FBTA05

Arm

Intervention/Treatment

Experimental: 1

Drug: FBTA05

Outcome Measures

Primary Outcome Measures

Phase I: Determination of the maximum tolerated dose (MTD) []
Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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