Back to resultsStudy of the Trifunctional Antibody FBTA05 and Donor Lymphocyte Infusion in B-cell Lymphoma After Allogeneic Stem Cell Transplantation (STP-LYM-01)
Primary Purpose
Leukemia, Stem Cell Transplantation
Status
Withdrawn
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
FBTA05
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- 3. Medizinische Klinik, Klinikum rechts der Isar der TU München
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Phase I: Determination of the maximum tolerated dose (MTD)
Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
Secondary Outcome Measures
Full Information
NCT ID
NCT01138579
First Posted
June 4, 2010
Last Updated
December 5, 2022
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01138579
Brief Title
Study of the Trifunctional Antibody FBTA05 and Donor Lymphocyte Infusion in B-cell Lymphoma After Allogeneic Stem Cell Transplantation
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment delayed, trial medication no loner available
Study Start Date
August 2010 (Anticipated)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Stem Cell Transplantation
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FBTA05
Primary Outcome Measure Information:
Title
Phase I: Determination of the maximum tolerated dose (MTD)
Title
Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
3. Medizinische Klinik, Klinikum rechts der Isar der TU München
City
Munich
State/Province
Bavaria
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34515338
Citation
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
Results Reference
derived
PubMed Identifier
23815981
Citation
Buhmann R, Michael S, Juergen H, Horst L, Peschel C, Kolb HJ. Immunotherapy with FBTA05 (Bi20), a trifunctional bispecific anti-CD3 x anti-CD20 antibody and donor lymphocyte infusion (DLI) in relapsed or refractory B-cell lymphoma after allogeneic stem cell transplantation: study protocol of an investigator-driven, open-label, non-randomized, uncontrolled, dose-escalating Phase I/II-trial. J Transl Med. 2013 Jul 2;11:160. doi: 10.1186/1479-5876-11-160.
Results Reference
derived
Learn more about this trial
Study of the Trifunctional Antibody FBTA05 and Donor Lymphocyte Infusion in B-cell Lymphoma After Allogeneic Stem Cell Transplantation
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