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We provide in vivo pharmacology and translational studies for lentiviral vector-based in vivo CAR-T programs, evaluating in vivo CAR-T generation, expansion, tissue distribution, anti-tumor activity, pharmacodynamic responses, and early safety across relevant preclinical models.
Our studies integrate vector exposure with CAR-T kinetics and therapeutic response to support candidate evaluation, dose-response assessment, biomarker development, and subsequent preclinical development decisions.
Key Capabilities
Model selection is matched to the CAR target, tumor biology, immune context, and study objectives. We provide complementary model systems to characterize in vivo CAR-T activity from cellular generation to therapeutic response.
Humanized models support evaluation of human T-cell targeting, in vivo CAR-T generation, expansion, persistence, and anti-tumor activity in a human immune-cell context.
Model Options Include:
CDX models provide controlled and reproducible tumor settings for proof-of-concept, dose-response, and anti-tumor efficacy studies.
Model Options Include
PDX models can support evaluation of in vivo CAR-T activity using patient-derived tumors selected according to target expression, tumor characteristics, and study objectives.
Model Options Include
Syngeneic models provide an immunocompetent setting for evaluating immune pharmacology, tumor–immune interactions, cytokine responses, and treatment-related tolerability. Their application to in vivo CAR-T studies is selected according to vector tropism, target compatibility, CAR cross-reactivity, and the biological relevance of the model.
Model Options Include
Target biology
Target expression
Tumor type
Immune context
Vector strategy
Study objective
We evaluate whether vector administration results in functional CAR-T generation and whether CAR-T cells expand, persist, localize to relevant tissues, and produce measurable pharmacodynamic and anti-tumor responses.
Following vector administration, we evaluate vector-mediated T-cell transduction and CAR expression to characterize the generation of CAR-T cells in vivo.
Key Readouts
Longitudinal assessment of CAR+ T cells provides information on the kinetics of in vivo CAR-T expansion and persistence. Where appropriate, immune phenotyping can further characterize the cellular state associated with treatment response.
Key Readouts
Therapeutic activity is assessed using tumor burden, tumor growth, and survival endpoints together with CAR-T pharmacology data.
Key Readouts
In vivo CAR-T pharmacology requires distinction between vector exposure, CAR-T cell distribution, and downstream biological response. We integrate these complementary assessments to characterize vector disposition, CAR-T tissue kinetics, and pharmacodynamic activity across relevant tissues.
Key Readouts
Vector Biodistribution
Assess vector exposure and tissue distribution following administration to characterize vector presence in blood and relevant tissues and to evaluate distribution beyond the intended target compartment.
CAR-T Cell Distribution
Quantify CAR+ T cells in blood, tumor, lymphoid tissues, and other relevant organs to characterize CAR-T trafficking, tissue localization, and persistence.
Pharmacodynamic Assessment
Link CAR-T generation and tissue exposure with downstream biological responses to evaluate target engagement, immune activation, and treatment-related pharmacodynamic effects.
Early safety assessment can be integrated into in vivo CAR-T pharmacology studies to identify treatment-related findings and inform subsequent safety strategy. The assessment is tailored to the vector platform, CAR target, dosing regimen, model, and study duration.
| Assessment Area | Typical Evaluations |
| General Tolerability | Body weight, clinical observations, survival, and overall animal condition |
| Immune Response | Cytokine profiling, peripheral immune-cell changes, and inflammation-related markers |
| Clinical Pathology | Hematology and selected serum biochemistry parameters |
| Tissue Assessment | Organ observations, tissue collection, and histopathological evaluation |
| Target-Related Risk | Assessment of treatment-related findings in target-expressing or vector-exposed tissues |
Safety assessments can be incorporated into efficacy studies or expanded into dedicated preclinical safety programs according to project requirements.
In vivo CAR-T pharmacology requires coordinated assessment of vector exposure, CAR-T kinetics, therapeutic activity, and safety. We design studies around the development question rather than treating each endpoint as an isolated assay.
Integrated Evaluation:
This integrated approach helps identify relationships between in vivo CAR-T kinetics and therapeutic response and provides a clearer basis for candidate and study progression.
Integrate vector exposure, CAR-T kinetics, biodistribution, pharmacodynamic response, efficacy, and safety-relevant findings within a coordinated study framework.
Select model systems according to target biology, vector characteristics, tumor context, immune environment, and study objectives.
Characterize CAR-T generation, expansion, persistence, tissue distribution, immune activity, and therapeutic response.
Connect cellular kinetics and pharmacodynamic findings with efficacy outcomes to support candidate evaluation and subsequent development planning.
What models are suitable for in vivo CAR-T studies?
Model selection depends on the CAR target, tumor type, immune context, and study objective. Humanized models are particularly useful when evaluation of human T-cell targeting and CAR-T generation is required, while CDX, PDX, and syngeneic models provide complementary tumor and immune settings.
Can you evaluate CAR-T expansion and persistence in vivo?
Yes. Longitudinal analysis of CAR+ T cells can be incorporated to characterize in vivo CAR-T generation, expansion kinetics, peak levels, and persistence over the study period.
Do you evaluate vector biodistribution?
Vector biodistribution can be incorporated into the study to characterize vector exposure across blood and relevant tissues. CAR-T cell distribution can be assessed separately to distinguish vector exposure from the distribution of generated CAR-T cells.
Can pharmacodynamic biomarkers be included?
Yes. PD endpoints can be selected according to the CAR target, tumor model, mechanism of action, and available analytical methods. Cytokines, immune-cell changes, CAR expression, and target-related biomarkers may be incorporated where appropriate.
Can the study be customized?
Yes. Model selection, dose groups, administration strategy, sampling time points, efficacy endpoints, biodistribution, PD, and safety assessments can be configured according to the development stage and study objectives.
Discuss your CAR target, lentiviral vector strategy, model requirements, and key pharmacology questions with our scientific team.
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