CAR-T Preclinical Characterization in vivo
Chimeric antigen receptors (CARs) are receptor proteins that are engineered to give T cells new abilities to recognize specific targets. The receptors are chimeric because they combine both antigen-binding and T-cell activating functions into a single receptor. The premise of CAR-T immunotherapy is to modify T cells to recognize cancer cells in order to more effectively target and destroy them.
In order to apply CAR-T therapy in more conditions effectively and efficiently, preclinical assays on animal models are necessary for approval of clinical trials based on CAR-T therapy. The in vivo assays of CAR-T therapy mainly focus on characteristics, working mechanism, applicable conditions, suitable population, pathways, and target sites of CAR-T medical products.
Pharmacological, as well as Pharmacokinetic, Evaluation are Essential for CAR-T Therapies (including but not limited to)
- Target expression detection includes target binding sites and target expressing sites
- Functional analysis includes proliferation assay, cytokine secretion detection, targeting antigen distribution assay, and affinity analysis
- Anti-tumor efficacy includes tumor-killing ability detection
- In vivo Biodistribution analysis in vivo includes CAR-T exposure level detection by time, retaining duration assay, and elimination assay by time
Additionally, Safety Assessment Needs to be Carefully Monitored (including but not limited to)
- CAR-T immune response analysis involves primary dose of CAR-T cells and cytotoxicity reaction
- CAR-T cytotoxicity effect detection involves neurotoxicity, immunotoxicity, and etc.
- Risk analysis of insertional mutation involves immortalized proliferation or tumorigenicity risk
- Long-term cytotoxicity and tumorigenicity assay involve insertion site analysis
- Cytokine release syndrome (CRS) analysis involves neurotoxicity, encephaledema, and etc.
- Safety analysis of virus vector involves type, biodistribution, proliferating level etc. of virus
- Risk of choice for model animals involves normal or disease-model animals
All of the in vivo preclinical characterization share the same principle: integration of pharmacological, pharmacokinetic, and safety analysis to establish the most efficient and cost-saving experiment for CAR-T medical products and CAR-T cells.
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