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Updated: Sep 20, 2025
Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
Published on: August 18, 2023
Recent advances and clinical pharmacology aspects of Chimeric Antigen Receptor (CAR) T-cellular therapy development
Johannes Kast1, Saeideh Nozohouri2, Di Zhou1
1Clinical Pharmacology, Modeling & Simulation, Amgen Inc., South San Francisco, California, USA.
Abstract:
Advances in immuno-oncology have provided a variety of novel therapeutics that harness the innate immune system to identify and destroy neoplastic cells. It is noteworthy that acceptable safety profiles accompany the development of these targeted therapies, which result in efficacious cancer treatment with higher survival rates and lower toxicities. Adoptive cellular therapy (ACT) has shown promising results in inducing sustainable remissions in patients suffering from refractory diseases. Two main types of ACT include engineered Chimeric Antigen Receptor (CAR) T cells and T cell receptor (TCR) T cells. The application of these immuno-therapies in the last few years has been successful and has demonstrated a safe and rapid treatment regimen for solid and non-solid tumors. The current review presents an insight into the clinical pharmacology aspects of immuno-therapies, especially CAR-T cells. Here, we summarize the current knowledge of TCR and CAR-T cell immunotherapy with particular focus on the structure of CAR-T cells, the effects and toxicities associated with these therapies in clinical trials, risk mitigation strategies, dose selection approaches, and cellular kinetics. Finally, the quantitative approaches and modeling techniques used in the development of CAR-T cell therapies are described.
Insights
Adoptive cellular therapy (ACT) utilizes engineered Chimeric Antigen Receptor (CAR) T cells and T cell receptor (TCR) T cells for cancer treatment. This review focuses on CAR-T cell clinical pharmacology, including safety, dosing, and modeling.
Area of Science:
- Immunology
- Oncology
- Pharmacology
Background:
- Immuno-oncology advances offer novel therapeutics targeting neoplastic cells.
- Adoptive cellular therapy (ACT), including CAR-T and TCR-T cells, shows promise for refractory diseases.
- These therapies demonstrate efficacy and safety in treating various tumors.
Purpose of the Study:
- To review the clinical pharmacology of immuno-therapies, focusing on Chimeric Antigen Receptor (CAR)-T cells.
- To summarize current knowledge on T cell receptor (TCR) and CAR-T cell immunotherapy.
- To detail CAR-T cell structure, clinical trial effects, toxicities, risk mitigation, dosing, and kinetics.
Main Methods:
- Literature review of immuno-oncology and adoptive cellular therapy.
- Focus on clinical pharmacology of CAR-T cells.
- Summary of quantitative approaches and modeling techniques in CAR-T cell therapy development.
Main Results:
- CAR-T and TCR-T cell therapies offer targeted cancer treatment with improved safety profiles.
- These therapies have shown success in both solid and non-solid tumors.
- Clinical trials indicate manageable toxicities and potential for sustainable remissions.
Conclusions:
- CAR-T cell therapy represents a significant advancement in cancer treatment.
- Understanding clinical pharmacology, including kinetics and dosing, is crucial for optimizing efficacy and safety.
- Quantitative modeling aids in the development and application of CAR-T cell therapies.
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