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Zanolimumab, a fully human monoclonal antibody: preliminary results of an ongoing clinical trial in CD4+ peripheral T-cell lymphomas (PTCL)

Zanolimumab, a fully human monoclonal antibody: preliminary results of an ongoing clinical trial in CD4+ peripheral T-cell lymphomas (PTCL)
Zanolimumab, a fully human monoclonal antibody: preliminary results of an ongoing clinical trial in CD4+ peripheral T-cell lymphomas (PTCL)
Zanolimumab (previously referred to as HuMax-CD4) is a fully human monoclonal IgG1k antibody. It is specific for the CD4 antigen expressed on a subset of T cells and has been shown to possess cytotoxic and anti-proliferative effects. We report initial clinical efficacy and safety results following treatment with 980 mg of zanolimumab in 15 patients diagnosed with biopsy-proven, treatment-refractory or relapsed CD4+ systemic PTCL. The following PTCL subtypes were included : enteropathy-type T-cell lymphoma (n=1), anaplastic large T-cell lymphoma (ALCL, n=3, 2 alk-negative, 1 alk-status unknown), angioimmunoblastic T-cell lymphoma (AIL, n=8) and PTCL-unspecified (PTCLu, n=3). The primary endpoint of the study was objective tumor response. Responses were based on CT scan and clinical examination and classified according to the Cheson criteria. Out of 15 patients enrolled, 4 responses have been seen; 2 PR (one patient later achieved a CRu) and 2 CRu verified by CT scan. Further, clinical improvements (marked decrease in the size of peripheral lymph nodes) were recorded in 2 additional patients. So far, a total of 21 SAEs has been reported. Of these, 4 were considered related to the study treatment: febrile neutropenia (n=1), thrombocytopenia (n=1), infusion related reaction (n=1) and hyperthermia (38.8° C) with hypotension (n=1). Eight unrelated deaths have been reported so far, all secondary to disease progression. In conclusion, in this heavily pretreated patient population, zanolimumab demonstrated a good tolerability profile and the present results indicate efficacy in the treatment of CD4-positive PTCL.
lymphoma, trial, monoclonal-antibody, time, monoclonal antibody, monoclonal-antibodies, t-cell
0006-4971
p.770A
d'Amore, Francesco
f5d22a45-658d-4a43-93e8-1071fc9c2b64
Relander, Thomas
f4927c80-8445-462e-bc65-cf2d420d936b
Jerkeman, Mats
52d57011-f86b-4986-a607-998b628d074a
Hagberg, Hans
656d57ec-d6fd-4a90-a7dd-c826d5da2711
Osterborg, Anders
5e4f7c9d-d019-47af-8d78-d54f14a4394c
Johnson, Peter
3f6068ce-171e-4c2c-aca9-dc9b6a37413f
Radford, John A.
deab9079-7116-454e-8d0a-03f1c52fae91
Hancock, Barry W.
240a7ccb-edc3-4194-9325-a5c3b1d6d593
Gramatzki, Martin
2e69f942-5997-4920-8b88-30d7ffe4c6b9
Schmitz, Norbert
04aac084-f1b0-4ebf-ae11-63481d509c0e
Tilly, Herve
35d7509b-a217-4f32-8cc8-3e4552de02e9
Morschhauser, Franck
a02f9f7f-4fbe-40d0-914c-2dccb9f14a0c
Lisby, STeen
643f1d35-e6a7-4b93-81ed-a68f8e11a87b
Baadsgaard, Ole
952a3c34-f53a-4a6d-aeac-68d182b4ebf4
d'Amore, Francesco
f5d22a45-658d-4a43-93e8-1071fc9c2b64
Relander, Thomas
f4927c80-8445-462e-bc65-cf2d420d936b
Jerkeman, Mats
52d57011-f86b-4986-a607-998b628d074a
Hagberg, Hans
656d57ec-d6fd-4a90-a7dd-c826d5da2711
Osterborg, Anders
5e4f7c9d-d019-47af-8d78-d54f14a4394c
Johnson, Peter
3f6068ce-171e-4c2c-aca9-dc9b6a37413f
Radford, John A.
deab9079-7116-454e-8d0a-03f1c52fae91
Hancock, Barry W.
240a7ccb-edc3-4194-9325-a5c3b1d6d593
Gramatzki, Martin
2e69f942-5997-4920-8b88-30d7ffe4c6b9
Schmitz, Norbert
04aac084-f1b0-4ebf-ae11-63481d509c0e
Tilly, Herve
35d7509b-a217-4f32-8cc8-3e4552de02e9
Morschhauser, Franck
a02f9f7f-4fbe-40d0-914c-2dccb9f14a0c
Lisby, STeen
643f1d35-e6a7-4b93-81ed-a68f8e11a87b
Baadsgaard, Ole
952a3c34-f53a-4a6d-aeac-68d182b4ebf4

d'Amore, Francesco, Relander, Thomas, Jerkeman, Mats, Hagberg, Hans, Osterborg, Anders, Johnson, Peter, Radford, John A., Hancock, Barry W., Gramatzki, Martin, Schmitz, Norbert, Tilly, Herve, Morschhauser, Franck, Lisby, STeen and Baadsgaard, Ole (2006) Zanolimumab, a fully human monoclonal antibody: preliminary results of an ongoing clinical trial in CD4+ peripheral T-cell lymphomas (PTCL). Blood, 108 (11), p.770A.

Record type: Article

Abstract

Zanolimumab (previously referred to as HuMax-CD4) is a fully human monoclonal IgG1k antibody. It is specific for the CD4 antigen expressed on a subset of T cells and has been shown to possess cytotoxic and anti-proliferative effects. We report initial clinical efficacy and safety results following treatment with 980 mg of zanolimumab in 15 patients diagnosed with biopsy-proven, treatment-refractory or relapsed CD4+ systemic PTCL. The following PTCL subtypes were included : enteropathy-type T-cell lymphoma (n=1), anaplastic large T-cell lymphoma (ALCL, n=3, 2 alk-negative, 1 alk-status unknown), angioimmunoblastic T-cell lymphoma (AIL, n=8) and PTCL-unspecified (PTCLu, n=3). The primary endpoint of the study was objective tumor response. Responses were based on CT scan and clinical examination and classified according to the Cheson criteria. Out of 15 patients enrolled, 4 responses have been seen; 2 PR (one patient later achieved a CRu) and 2 CRu verified by CT scan. Further, clinical improvements (marked decrease in the size of peripheral lymph nodes) were recorded in 2 additional patients. So far, a total of 21 SAEs has been reported. Of these, 4 were considered related to the study treatment: febrile neutropenia (n=1), thrombocytopenia (n=1), infusion related reaction (n=1) and hyperthermia (38.8° C) with hypotension (n=1). Eight unrelated deaths have been reported so far, all secondary to disease progression. In conclusion, in this heavily pretreated patient population, zanolimumab demonstrated a good tolerability profile and the present results indicate efficacy in the treatment of CD4-positive PTCL.

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More information

Published date: 16 November 2006
Additional Information: ASH Annual Meeting Abstracts, Poster Board Session: 901-II. Abstract 2723.
Keywords: lymphoma, trial, monoclonal-antibody, time, monoclonal antibody, monoclonal-antibodies, t-cell

Identifiers

Local EPrints ID: 62717
URI: http://eprints.soton.ac.uk/id/eprint/62717
ISSN: 0006-4971
PURE UUID: 4fcfc971-b47e-40e5-bc9a-1477afaeb302
ORCID for Peter Johnson: ORCID iD orcid.org/0000-0003-2306-4974

Catalogue record

Date deposited: 10 Nov 2008
Last modified: 14 Mar 2019 01:49

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Contributors

Author: Francesco d'Amore
Author: Thomas Relander
Author: Mats Jerkeman
Author: Hans Hagberg
Author: Anders Osterborg
Author: Peter Johnson ORCID iD
Author: John A. Radford
Author: Barry W. Hancock
Author: Martin Gramatzki
Author: Norbert Schmitz
Author: Herve Tilly
Author: Franck Morschhauser
Author: STeen Lisby
Author: Ole Baadsgaard

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