ArticleClinical and translational science2019
A Modeling Framework to Characterize Cytokine Release upon T-Cell-Engaging Bispecific Antibody Treatment: Methodology and Opportunities.
Article in Clinical and translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.
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Who cites it
30 citing papers in PubMed, 52 citations in OpenAlex.
- Teclistamab Dosing in Responders: Modeling and Simulation Results from the MajesTEC-1 Study in Relapsed/Refractory Multiple Myeloma.Targeted oncology · 2025Trial
- Cytokine release syndrome-compatible fever after initiation of local radiotherapy during late-phase epcoritamab therapy in relapsed/refractory diffuse large B-cell lymphoma: a case report.Journal of pharmaceutical health care and sciences · 2026Article
- Translational strategy to support the first-in-human study of a TCR-like T cell bispecific with anFrontiers in immunology · 2026Article
- Foundational Principles for the Quantitative Translation of T-Cell Therapeutics for Hematologic Malignancies and Immunology.Clinical pharmacology and therapeutics · 2026Review
- Leveraging in vitro Tumor Cell Killing and Cytokine Release to Predict Cytokine Release Syndrome Associated with CD3 T-cell Bispecifics in Oncology: a Retrospective Analysis.The AAPS journal · 2025Article
- Leveraging quantitative systems pharmacology modeling for elranatamab regimen optimization in relapsed or refractory multiple myeloma.NPJ systems biology and applications · 2025Article
- A Novel Two-Part Mixture Model for the Incidence and Time Course of Cytokine Release Syndrome After Elranatamab Dosing in Multiple Myeloma Patients.Clinical pharmacology and therapeutics · 2025Article
- Clinical Pharmacology of Cytokine Release Syndrome with T-Cell-Engaging Bispecific Antibodies: Current Insights and Drug Development Strategies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Review
- Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform.Frontiers in immunology · 2025Review
- Pharmacokinetics of Tarlatamab, a Delta-Like Ligand-3 (DLL3) Targeted Half-Life Extended Bispecific T-Cell Engager (BiTEClinical pharmacokinetics · 2024Article
- Tuning the potency and selectivity of ImmTAC molecules by affinity modulation.Clinical and experimental immunology · 2024Article
- An overview of statistical methods for biomarkers relevant to early clinical development of cancer immunotherapies.Frontiers in immunology · 2024Review
- Using protein geometry to optimize cytotoxicity and the cytokine window of a ROR1 specific T cell engager.Frontiers in immunology · 2024Article
- Teclistamab: Mechanism of action, clinical, and translational science.Clinical and translational science · 2024Review
- Coupling quantitative systems pharmacology modelling to machine learning and artificial intelligence for drug development: itsFrontiers in systems biology · 2024Article
- Mechanistic PKPD modeling to describe cytokine release associated with CD3 T-cell engager therapies.Frontiers in immunology · 2024Article
- Preclinical development of 1B7/CD3, a novel anti-TSLPR bispecific antibody that targets CRLF2-rearranged Ph-like B-ALL.Leukemia · 2023Article
- Phase 1 Study of Safety and Preliminary Clinical Activity of JNJ-63898081, a PSMA and CD3 Bispecific Antibody, for Metastatic Castration-Resistant Prostate Cancer.Clinical genitourinary cancer · 2023Article
- A Computational Model of Cytokine Release Syndrome during CAR T-cell Therapy.Advanced therapeutics · 2022Article
- Review
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
T-cell-engaging bispecific antibodies (T-BsAbs) are an important class of antibody therapeutics in immuno-oncology. T-BsAbs simultaneously bind to CD3 on T cells and a tumor-associated antigen on tumor cells, activate T cells, and redirect T cells' cytotoxicity against tumor cells. Cytokine release syndrome (CRS), a common dose-limiting adverse event for T-BsAbs, is associated with T-cell activation. A "priming" dose strategy (i.e., a lower initial dose followed by a higher maintenance dose) has been implemented in the clinic to mitigate CRS and to achieve efficacious doses with T-BsAbs. So far, the selection of the optimal priming dosing regimen is largely empirical. A "fit-for-purpose" semimechanistic pharmacokinetic/pharmacodynamic model was developed to characterize the cytokine release profiles upon T-BsAb treatment, including the priming effect observed with repeated dosing. This model can be utilized to simulate cytokine profiles following various dosing regimens and may assist the design of clinical dosing strategies for T-BsAbs programs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.