Multi-billion dollar AI drug developer streamlines sample collection and monitors immune response in Phase I trial with customized 40+ marker mass cytometry panel

Client

$3B+ AI drug developer running a Phase I trial

Goal

• See how the drug developer’s therapy alters immune cell composition in whole blood samples from patients in a Phase 1 trial.
  • Validate the detection of the drug-specific marker in whole blood samples
  • Establish <8% inter and intra-run precision for customized 40+ marker panel
  • Evaluate the drug’s overall impact on the immune system, with a particular focus on how it influences the expression of the custom marker across 700+ immune cell populations
  • Streamline sample collection for the Phase 1 clinical trial by replacing PBMC isolation and central lab processing with TokuKits, allowing for direct whole blood fixation at clinical sites

Method

• Teiko Custom Mass Cytometry Panel: 42 markers, 1 Custom Marker
• Sample type: Whole Blood fixed with TokuKits
• Sample Quantity: 100 whole blood samples across multiple dose cohorts and validation studies

Results

• Status: Ongoing
• For the custom marker, we validated detection in immune populations from both healthy volunteers and cancer patients
  • To determine the optimal staining concentration, we performed a standard six-point titration using our antibody verification process.
• We assessed how the drug affected immune cell subsets in both healthy controls and patient samples, observing dose-dependent changes across multiple populations. We also identified the cell populations that showed the most changes in their drug’s target after stimulation. 
• To demonstrate the robustness of the 41-marker backbone with the added custom marker, we generated a comprehensive assay qualification report for whole blood samples processed with TokuKits. We evaluated assay precision by examining both intra-run and inter-run variability.
  • Intra-run precision assessments showed a coefficient of variation (CV) below 3% across phenotypic frequencies, functional subsets, and median channel values (MCVs).
  • Inter-run precision demonstrated CVs under 8% for the same parameters, confirming reproducibility when different operators processed separate aliquots.
• To streamline clinical operations, we supplied TokuKits to clinical sites for direct sample collection. This approach allowed clinical sites to fix whole blood samples at the time of patient visits, reducing sample handling complexities and eliminating the need to send samples to a central lab for PBMC isolation.
• The trial remains ongoing, with samples being collected to track dose-dependent immune changes across over immune 700 subsets. This data is being used to uncover key immune signatures related to dose, response, and longitudinal trends.

Who Cares?

• This drug developer could measure their marker of interest while simultaneously measuring 750+ populations.
• By switching from PBMC to TokuKits, the drug developer saved $18K while adding 650+ populations to their analysis.