June 25, 2025 | BALTIMORE – We are thrilled to share that a major milestone in cell therapy has just been published in Cell, showcasing the world’s first-in-human clinical study of dual-targeting CAR-NK cells derived from induced pluripotent stem cells (iPSCs). The therapy demonstrated promising efficacy with an excellent safety profile—no signs of cytokine release syndrome (CRS), neurotoxicity, or graft-versus-host disease (GvHD). This represents a paradigm shift toward scalable, off-the-shelf immune cell therapy solutions. — But what powers the safety, monitoring, and mechanistic understanding behind such a novel therapy? The answer lies in Complete360®, our proprietary clinical-grade deep plasma proteomics platform.
Why Traditional Tools Fall Short for Next-Generation Therapies
Conventional tools like ELISA panels, Olink assays, or basic LC-MS platforms offer limited coverage—typically quantifying fewer than 1,000 analytes with low throughput and variable reproducibility. While sufficient for some routine measurements, they simply cannot provide the depth, consistency, and breadth needed for modern immunotherapies.
In contrast, Complete360® was purpose-built to meet the emerging demands of complex biologics and precision medicine.
Complete360®: Setting a New Benchmark in Clinical Plasma Proteomics
| Capability | Complete360® Platform | Traditional Platforms |
|---|---|---|
| Protein coverage | >10,000 plasma proteins (cytokines, enzymes, receptors) | Typically <1000 pre-defined targets |
| Sensitivity | Attomole-level; supports low-volume plasma | Nanomolar-level; poor detection of rare events |
| Reproducibility | Inter-batch CV <5%; validated for clinical use | High variability between runs |
| Clinical compatibility | Fully CLIA/CAP-compliant; LDT/FDA-ready | Often limited to research-only applications |
| Data intelligence | AI-assisted interpretation and longitudinal tracking | Manual curation, limited scalability |
How Complete360® Supports CAR‑NK Therapeutics
In the featured Cell study, researchers faced multiple challenges:
How to track CAR-NK expansion and persistence in circulation?
How to monitor immune response and toxicity risk (e.g., CRS)?
How to assess host immune recognition of iPSC-derived cells?
How to generate standardized, regulator-ready clinical data?
Complete360® provided a one-stop solution:
Deep profiling of >10,000 proteins from a single 240 µL plasma sample;
Simultaneous quantification of cytokines, CAR markers, apoptosis factors, metabolic signatures, and host response proteins;
Standardized workflows that support multi-site clinical trials and regulatory submission;
Integration-ready data output, compatible with genomics, metabolomics, and single-cell datasets.
From Biomarker Discovery to Regulatory Filing—A Platform Built for Translation
Complete360® is not just another proteomics tool—it’s a clinical infrastructure designed to power the next generation of therapeutics. Whether you’re developing off-the-shelf cell therapies, engineering CAR constructs, or monitoring immune responses to biologics, our platform provides:
Early toxicity detection through unbiased cytokine profiling;
Therapeutic efficacy tracking via dynamic immune and tumor-related protein signatures;
Mechanism-of-action insights integrated across systems biology layers;
Scalable sample throughput for both discovery and late-stage trials.
A Clinical Proteomics Platform for the Therapies of Tomorrow
Complete360® is revolutionizing how we evaluate, de-risk, and accelerate innovative therapies. From IND-enabling studies to large-scale multi-center trials, we provide unmatched depth, precision, and confidence in blood-based biomarker assessment.
We don’t just measure. We illuminate.
— Qing Wang, Founder and CEO
Let’s Collaborate
If your team is working on:
CAR-T, CAR-NK, or iPSC-derived cellular therapies,
Disease biomarker discovery and validation,
Clinical trial assay development,
Or translational research programs requiring regulatory-grade data,
We’d love to collaborate—please contact us to explore how our clinical-grade plasma proteomics platform Complete360® can accelerate your biomarker discovery or precision diagnostics project.
Post a comment