A Multicenter, Dose-Escalation, Phase 1 Study of Samalizumab (ALXN6000) to Evaluate the Pharmacokinetics, Safety, and Tolerability in Patients With Advanced Cancer

This is a multicenter, open-label, dose-escalation, Phase 1 study of intravenous (IV) samalizumab to determine its maximum tolerated dose (MTD), overall safety/tolerability, pharmacokinetic and pharmacodynamic parameters, and efficacy in participants with advanced cancer. The study was terminated for administrative reasons and not due to any safety concerns.

Start Date17 Nov 2016

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

[+1]

NCT00648739 / TerminatedPhase 1/2

A Phase I/II Open Label Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of ALXN6000 In Patients With Relapsing Or Refractory B-Cell Chronic Lymphocytic Leukemia Or Multiple Myeloma

The purpose of this study was to determine the safety and maximum tolerated dose (MTD) of ALXN6000 (samalizumab) in treating relapsing or refractory B-cell chronic lymphocytic leukemia (B-CLL) or multiple myeloma (MM) and to study how samalizumab may help the immune system fight tumors that express CD200.

Start Date19 Jun 2008

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

100 Clinical Results associated with Samalizumab

100 Translational Medicine associated with Samalizumab

100 Patents (Medical) associated with Samalizumab

Literatures (Medical) associated with Samalizumab

04 Feb 2023·Oncotarget

The immunoregulatory protein CD200 as a potentially lucrative yet elusive target for cancer therapy

Review

Author: Shao, Anqi ; Owens, David M.

CD200 is an immunoregulatory cell surface ligand with proven pro-tumorigenic credentials via its ability to suppress CD200 receptor (CD200R)-expressing anti-tumor immune function. This definitive role for the CD200-CD200R axis in regulating an immunosuppressive tumor microenvironment has garnered increasing interest in CD200 as a candidate target for immune checkpoint inhibition therapy. However, while the CD200 blocking antibody samalizumab is still in the early stages of clinical testing, alternative mechanisms for the pro-tumorigenic role of CD200 have recently emerged that extend beyond direct suppression of anti-tumor T cell responses and, as such, may not be susceptible to CD200 antibody blockade. Herein, we will summarize the current understanding of CD200 expression and function in the tumor microenvironment as well as alternative strategies for potential neutralization of multiple CD200 mechanisms in human cancers.

01 Dec 2019·Journal for ImmunoTherapy of CancerQ2 · MEDICINE

Phase I study of samalizumab in chronic lymphocytic leukemia and multiple myeloma: blockade of the immune checkpoint CD200

Q2 · MEDICINE

ArticleOA

Author: Faas, Susan J ; Whelden, Maria ; Bedrosian, Camille L ; Farber, Charles ; Mahadevan, Daruka ; Lanasa, Mark C ; Ulery, Terrie ; Zhang, Xiaoping ; Li, Lan ; Pandey, Manjari ; Kukreja, Anjli ; Heffner, Leonard T

PURPOSESamalizumab is a novel recombinant humanized monoclonal antibody that targets CD200, an immunoregulatory cell surface member of the immunoglobulin superfamily that dampens excessive immune responses and maintains self-tolerance. This first-in-human study investigated the therapeutic use of samalizumab as a CD200 immune checkpoint inhibitor in chronic lymphocytic leukemia (CLL) and multiple myeloma (MM).EXPERIMENTAL DESIGNTwenty-three patients with advanced CLL and 3 patients with MM were enrolled in an open-label phase 1 study (NCT00648739). Patients were assigned sequentially to one of 7 dose level cohorts (50 to 600 mg/m²) in a 3 + 3 study design, receiving a single dose of samalizumab intravenously once every 28 days. Primary endpoints were safety, identification of the maximum tolerated dose (MTD), and pharmacokinetics. Secondary endpoints were samalizumab binding to CD200, pharmacodynamic effects on circulating tumor cells and leukocyte subsets, and clinical responses.RESULTSTwenty-one patients received > 1 treatment cycle. Adverse events (AEs) were generally mild to moderate in severity. Samalizumab produced dose-dependent decreases in CD200 expression on CLL cells and decreased frequencies of circulating CD200 + CD4+ T cells that were sustained at higher doses. The MTD was not reached. Decreased tumor burden was observed in 14 CLL patients. One CLL patient achieved a durable partial response and 16 patients had stable disease. All MM patients had disease progression.CONCLUSIONSSamalizumab had a good safety profile and treatment was associated with reduced tumor burden in a majority of patients with advanced CLL. These preliminary positive results support further development of samalizumab as an immune checkpoint inhibitor.TRIAL REGISTRATIONClinicalTrials.gov, NCT00648739 registered April 1, 2008.

100 Deals associated with Samalizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09961	Samalizumab	-	DB12636

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	-	The Leukemia & Lymphoma Society of Canada	-
Acute Myeloid Leukemia	Phase 2	-	Alexion Pharmaceuticals, Inc.	-
Advanced cancer	Preclinical	US	Alexion Pharmaceuticals, Inc.	17 Nov 2016
Advanced Malignant Solid Neoplasm	Preclinical	US	Alexion Pharmaceuticals, Inc.	17 Nov 2016
Chronic lymphocytic leukaemia refractory	Preclinical	US	Alexion Pharmaceuticals, Inc.	19 Jun 2008
Chronic Lymphocytic Leukemia	Preclinical	US	Alexion Pharmaceuticals, Inc.	19 Jun 2008
Multiple Myeloma	Preclinical	US	Alexion Pharmaceuticals, Inc.	19 Jun 2008

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00648739 (Pubmed \| J Immunother Cancer) Manual	Phase 1/2	Chronic Lymphocytic Leukemia \| Multiple Myeloma	26	samalizumab	(obvqjzsuiw) = generally mild to moderate in severity vhmnulgnkv (xojunpmoaf )	Positive	23 Aug 2019
NCT00648739 (CTgov)	Phase 1/2	Multiple Myeloma \| Chronic lymphocytic leukaemia refractory	26	Samalizumab	hogbbdkehx(lcjdrlkwqo) = xdknsxbiqr bvgcytlfet (xrmiiuazvf, yxbkxojeau - xyyoibfedd)	-	05 Mar 2019

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