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

NCT01138579 | Withdrawn Phase 1 DMC

• 1 other identifier: STP-LYM-01-V01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Phase I: Determination of the maximum tolerated dose (MTD)

• Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI

Study Arms (1)

1

EXPERIMENTAL

Drug: FBTA05

Interventions

FBTA05 DRUG

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

3. Medizinische Klinik, Klinikum rechts der Isar der TU München

Munich, Bavaria, Germany

Location

Related Publications (2)

• 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.

  PMID: 34515338 DERIVED

• 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.

  PMID: 23815981 DERIVED

MeSH Terms

Conditions

Leukemia; Lymphoma, Non-Hodgkin

Interventions

Bi20 antibody

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 7, 2022

Record last verified: 2015-12

Locations

DE (1)