Summary of a workshop on preclinical and translational safety assessment of CD3 bispecifics

A Translational Quantitative Systems Pharmacology Model for CD3 Bispecific Molecules: Application to Quantify T Cell-Mediated Tumor Cell Killing by P-Cadherin LP DART®

(2019) Alison Betts et al.   AAPS Journal

A Mucin 16 bispecific T cell–engaging antibody for the treatment of ovarian cancer

(2019) Alison Crawford et al.   Science Translational Medicine

CD3 bispecific antibody–induced cytokine release is dispensable for cytotoxic T cell activity

(2019) Ji Li et al.   Science Translational Medicine

Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia

(2018) Nicola Gökbuget et al.   BLOOD

Improved CNS exposure to tocilizumab after cerebrospinal fluid compared to intravenous administration in rhesus macaques

(2018) Anandani Nellan et al.   BLOOD

Relative Target Affinities of T-Cell–Dependent Bispecific Antibodies Determine Biodistribution in a Solid Tumor Mouse Model

(2018) Danielle Mandikian et al.   MOLECULAR CANCER THERAPEUTICS

Development of MGD007, a gpA33 x CD3 bispecific DART® protein for T-cell immunotherapy of metastatic colorectal cancer

(2018) Paul A Moore et al.   MOLECULAR CANCER THERAPEUTICS

Monocyte-derived IL-1 and IL-6 are differentially required for cytokine-release syndrome and neurotoxicity due to CAR T cells

(2018) Margherita Norelli et al.   NATURE MEDICINE

FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell‐Induced Severe or Life‐Threatening Cytokine Release Syndrome

(2018) Robert Q. Le et al.   ONCOLOGIST

FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B‐Cell Acute Lymphoblastic Leukemia

(2018) E. Dianne Pulte et al.   ONCOLOGIST

T cell engaging bispecific antibody (T-BsAb): From technology to therapeutics

(2018) Z. Wu et al.   PHARMACOLOGY & THERAPEUTICS

Dexamethasone-induced immunosuppression: mechanisms and implications for immunotherapy

(2018) Amber J. Giles et al.   Journal for ImmunoTherapy of Cancer

Cytokine release syndrome

(2018) Alexander Shimabukuro-Vornhagen et al.   Journal for ImmunoTherapy of Cancer

Neurologic adverse events in patients with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab: management and mitigating factors

(2018) Anthony S. Stein et al.   ANNALS OF HEMATOLOGY

Systematic Evaluation of Neurotoxicity in Children and Young Adults Undergoing CD22 Chimeric Antigen Receptor T-Cell Therapy

(2018) Haneen Shalabi et al.   JOURNAL OF IMMUNOTHERAPY

An approved in vitro approach to preclinical safety and efficacy evaluation of engineered T cell receptor anti-CD3 bispecific (ImmTAC) molecules

(2018) Jane Harper et al.   PLoS One

ASBMT Consensus Grading for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells

(2018) Daniel W Lee et al.   BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION

Bispecific T-cell engagers: Towards understanding variables influencing the in vitro potency and tumor selectivity and their modulation to enhance their efficacy and safety

(2018) Diego Ellerman   METHODS

Avidity-based binding to HER2 results in selective killing of HER2-overexpressing cells by anti-HER2/CD3

(2018) Dionysos Slaga et al.   Science Translational Medicine

FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease

(2018) Emily Y. Jen et al.   CLINICAL CANCER RESEARCH

The making of bispecific antibodies

(2017) Ulrich Brinkmann et al.   mAbs

NKG2D Ligand–Targeted Bispecific T-Cell Engagers Lead to Robust Antitumor Activity against Diverse Human Tumors

(2017) Claire Godbersen et al.   MOLECULAR CANCER THERAPEUTICS

Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia

(2017) Hagop Kantarjian et al.   NEW ENGLAND JOURNAL OF MEDICINE

An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection

(2017) Haleh Saber et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Endothelial Activation and Blood–Brain Barrier Disruption in Neurotoxicity after Adoptive Immunotherapy with CD19 CAR-T Cells

(2017) Juliane Gust et al.   Cancer Discovery

An anti-CD3/anti–CLL-1 bispecific antibody for the treatment of acute myeloid leukemia

(2016) Steven R. Leong et al.   BLOOD

A phase I trial of the trifunctional anti Her2 × anti CD3 antibody ertumaxomab in patients with advanced solid tumors

(2016) N. Haense et al.   BMC CANCER

Phase 1 Dose Escalation Study of MEDI-565, a Bispecific T-Cell Engager that Targets Human Carcinoembryonic Antigen, in Patients With Advanced Gastrointestinal Adenocarcinomas

(2016) Michael Pishvaian et al.   Clinical Colorectal Cancer

Cytokine release: A workshop proceedings on the state-of-the-science, current challenges and future directions

(2016) Christine Grimaldi et al.   CYTOKINE

Immunotherapeutic implications of IL-6 blockade for cytokine storm

(2016) Toshio Tanaka et al.   Immunotherapy

Bispecific T-Cell Engager (BiTE) Antibody Construct Blinatumomab for the Treatment of Patients With Relapsed/Refractory Non-Hodgkin Lymphoma: Final Results From a Phase I Study

(2016) Maria-Elisabeth Goebeler et al.   JOURNAL OF CLINICAL ONCOLOGY

Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia

(2016) N Gökbuget et al.   Blood Cancer Journal

Cytokine release syndrome with novel therapeutics for acute lymphoblastic leukemia

(2016) N. V. Frey et al.   Hematology-American Society of Hematology Education Program

FDA Approval: Blinatumomab

(2015) D. Przepiorka et al.   CLINICAL CANCER RESEARCH

B7H6-Specific Bispecific T Cell Engagers Lead to Tumor Elimination and Host Antitumor Immunity

(2015) Ming-Ru Wu et al.   JOURNAL OF IMMUNOLOGY

Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study

(2015) Max S Topp et al.   LANCET ONCOLOGY

Alternative molecular formats and therapeutic applications for bispecific antibodies

(2015) Christoph Spiess et al.   MOLECULAR IMMUNOLOGY

A CD3xCD123 bispecific DART for redirecting host T cells to myelogenous leukemia: Preclinical activity and safety in nonhuman primates

(2015) Gurunadh R. Chichili et al.   Science Translational Medicine

Scientific and Regulatory Policy Committee Points-to-consider Paper*

(2015) Kendall S. Frazier et al.   TOXICOLOGIC PATHOLOGY

Current concepts in the diagnosis and management of cytokine release syndrome

(2014) D. W. Lee et al.   BLOOD

Immunotherapy with the trifunctional anti-CD20 x anti-CD3 antibody FBTA05 (Lymphomun) in paediatric high-risk patients with recurrent CD20-positive B cell malignancies

(2014) Friedhelm R. Schuster et al.   BRITISH JOURNAL OF HAEMATOLOGY

Antitumor Efficacy of a Bispecific Antibody That Targets HER2 and Activates T Cells

(2014) T. T. Junttila et al.   CANCER RESEARCH

Cytokine release assays: Current practices and future directions

(2014) D. Finco et al.   CYTOKINE

Preculture of PBMCs at high cell density increases sensitivity of T-cell responses, revealing cytokine release by CD28 superagonist TGN1412

(2011) P. S. Romer et al.   BLOOD

B-cell depletion and remissions of malignancy along with cytokine-associated toxicity in a clinical trial of anti-CD19 chimeric-antigen-receptor-transduced T cells

(2011) J. N. Kochenderfer et al.   BLOOD

Cancer Immunotherapy Using a Bispecific NK Receptor Fusion Protein that Engages both T Cells and Tumor Cells

(2011) T. Zhang et al.   CANCER RESEARCH

In vitro cytokine release assays for predicting cytokine release syndrome: The current state-of-the-science. Report of a European Medicines Agency Workshop

(2010) Jean-Marc Vidal et al.   CYTOKINE

Effect of inflammation on kidney function and pharmacokinetics of COX-2 selective nonsteroidal anti-inflammatory drugs rofecoxib and meloxicam

(2008) Sam Harirforoosh et al.   JOURNAL OF APPLIED TOXICOLOGY