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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Leukemia, Stem Cell Transplantation

Intervention / Treatment
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* Drug: FBTA05


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: FBTA05<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: Determination of the maximum tolerated dose (MTD) |  |  | 
| Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FBTA05, CD20, CLL, NHL, DLI, allogeneic transplantation, CD20 positive chronic lymphocytic leukemia (CLL), low and high grade non-Hodgkin´s lymphoma (NHL) after allogeneic stem cell transplantation with active disease