Biomarker Analysis Service for ICANS Risk Prediction

Safeguard Your Pipeline with Precision Diagnostics

Immune effector cell-associated neurotoxicity syndrome (ICANS) occurs in up to 65% of CAR-T recipients and lacks reliable early predictors. Recent studies highlight the prognostic value of cytokine kinetics (e.g., IL-6, GM-CSF), CSF biomarkers, EEG patterns, and inflammatory gene signatures. Creative Biolabs converts these insights into reliable, accessible biomarker analysis services that support informed decision-making.

Creative Biolabs provides modular and customizable services, including:

• Multiplex cytokine/chemokine panels for serum and CSF
• Time-point-based kinetic biomarker quantification (baseline to peak toxicity)
• Electroencephalogram (EEG) pre/post-infusion signal processing and GTE scoring
• Machine learning models for personalized ICANS risk prediction
• Transcriptome-wide cytokine-driven immune cell subset analysis
• Clinical stratification reports with actionable toxicity guidance

Our services empower teams to de-risk CAR-T programs by identifying high-risk patients, optimizing early interventions, and justifying safety switch inclusion. We provide reproducible, validated, and regulatory-informative biomarker outputs that guide decision-making in both discovery and clinical phases.

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Strategies

Our ICANS biomarker framework combines:

• Peripheral and CSF-based cytokine profiling (IL-1, IL-6, GM-CSF, MCP-1, IFN-γ)
• Analysis of Inflammatory Risk Signatures Based on CRP, Ferritin, LDH, and D-Dimer Levels
• Neural injury markers (e.g., neurofilament light, GFAP) in serum/CSF
• Pre-treatment EEG GTE scoring for electrical vulnerability mapping
• Transcriptomic and machine learning-based immune clustering
• Longitudinal kinetic modeling of cytokine release trajectories

This multi-layered strategy integrates dynamic, cellular, and molecular insights to anticipate ICANS onset and severity.

Workflow

Required Starting Materials

• CAR target and construct schematic (CD19, BCMA, etc.)
• Patient cohort metadata (e.g., age, tumor burden, baseline labs)
• Sample matrix type and collection schedule
• Preclinical or clinical ICANS observations (if available)

Highlights

Deep immunoneuro signature resolution

We analyze serum and CSF cytokine gradients, integrating them with neural injury markers and immune cell signatures to deliver high-resolution toxicity insights.

Proactive patient stratification

Our risk scoring tools allow early identification of high-risk patients before severe symptoms emerge, enabling tailored monitoring and intervention plans.

Validated across platforms

Assays are compatible with flow cytometry, ELISA, Luminex, and sequencing workflows, ensuring reproducibility and platform integration flexibility.

Modular and customizable

Each biomarker module can be selected independently or bundled, supporting both exploratory and regulated study requirements.

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Publication

This diagram presents a systematic framework for organizing known risk factors associated with ICANS. The factors are broadly categorized into host-related, cellular therapy-related, and inflammation-related groups. Notably, certain key elements, such as cytokine release syndrome (CRS), function as bridges across these categories, highlighting their central role in ICANS pathogenesis. Risk factors with the strongest supporting evidence are emphasized in bold, offering a focused foundation for risk assessment, early intervention, and improved clinical management of ICANS.

Fig.1 A structured framework for categorizing established risk factors associated with ICANS.¹

Customer Reviews

• Improved risk prediction
  Using Creative Biolabs' biomarker service helped us identify a pre-treatment IL-6 and MCP-1 surge pattern that strongly correlated with ICANS onset in our BCMA CAR-T cohort. Mar 2025, Dr. T*** Chang
• Enhanced patient selection
  Their EEG-GTE analysis allowed us to flag high-risk subjects before infusion. This changed our monitoring protocol and likely avoided escalation. Jan 2025, Dr. E*** Ruiz
• Mechanism-informed safety design
  The single-cell analysis of cytokine-producing T cell subsets clarified why our dual-target CAR had higher neurotoxicity, leading to a safer revision. Jun 2025, Dr. K*** Lin

FAQs

Extended Services

Creative Biolabs delivers advanced biomarker discovery and ICANS mitigation strategies that empower CAR-T developers to move forward safely and confidently. From discovery to preclinical support, our services are built for precision, flexibility, and speed.

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Reference

1. Butt, Omar H., et al. "A systematic framework for predictive biomarkers in immune effector cell-associated neurotoxicity syndrome." Frontiers in Neurology 14 (2023): 1110647. Distributed under Open Access license CC BY 4.0, without modification.