# A Single-Cell Proteomic instrument for Predictive Product Quality Check in Autologous CAR-T Immunotherapies

> **NIH NIH R44** · ISOPLEXIS, INC. · 2021 · $1,150,207

## Abstract

While CAR-T therapies have advanced in the clinic, there are still two specific issues using these breakthrough
therapies for blood cancers: Durable responses in patients are only at 30-50% and Cytokine Release Syndrome
occurs in 60-90% of treated patients. These limitations, for a drug that costs as much as $500,000, may cost an
additional $250,000+ for treating adverse events leading to caution for many clinical centers to administer these
therapies. IsoPlexis is developing its technology to predict responders, non-responders, and toxicity in patients,
directly from the CAR T cell therapy product prior to entry in the patients. This would allow clinical centers to
provide improved product release criteria improving CAR T therapy production and potentially increasing patient
response while reducing expensive side effects. IsoPlexis recently published in the journal Blood in July of 2018
showing that across a National Cancer Institute Trial of 20 NHL patients, only the IsoCode Single-Cell Chip
predicted responders and non-responders (p = 0.0119), where existing product evaluation technologies like flow
cytometry and bulk ELISA did not. The IsoCode’s ability to detect 40+ secreted proteins per cell identified unique
polyfunctional cells in responding patients (in a metric termed PSI). This published work with Kite Pharma and
the NCI also demonstrated the ability to predict certain types of toxicities in combination with in vivo metrics,
including grade 3+ neurotoxicity (p = 0.0007) and cytokine release syndrome (p = 0.0085). In its NCI phase II
CAR-T SBIR, IsoPlexis validated this CAR-T IsoCode Chip, and built and tested the fully automated workflow
for the IsoCode Chip on the IsoLight instrument. The IsoLight is a sample-to-answer device on which users can
process 8 samples simultaneously. Images are taken overnight through a 3 laser-based optics system, and back-
end ELISA steps are run in an automated fashion. The CAR-T polyfunctional results are directly available in the
IsoSpeak software suite. The instrument is now working and analyzing CAR-T samples. IsoPlexis’ IsoCode Chip,
for use in CAR-T, was recognized as the #1 Innovation of 2017 by the Scientist Magazine, as well as Fierce Life
Sciences. The IsoLight instrument was recognized for ease of use by the leading Global Red Dot Design Award,
and IsoSpeak was recognized as Top 10 Innovation by Pharma Tech Outlook. The Phase IIB goal advances the
IsoLight RUO system and clinically validates the IsoCode and IsoLight across centers delivering an IsoLight Dx
to provide the autologous T cell therapy market predictive therapeutic product evaluation. Aim 1: Develop
automation for manufacturing consumable chip to meet larger production needs. Aim 2: Development of
enterprise software modules, including CFR Part 211 compliance to enable GMP pharmaceutical environment
for CAR-T product release. Aim 3: Develop automated IsoLight production and calibration processes verifying
with four instruments over ...

## Key facts

- **NIH application ID:** 10151540
- **Project number:** 5R44CA210841-06
- **Recipient organization:** ISOPLEXIS, INC.
- **Principal Investigator:** Timothy S McConnell
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,150,207
- **Award type:** 5
- **Project period:** 2016-09-21 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10151540

## Citation

> US National Institutes of Health, RePORTER application 10151540, A Single-Cell Proteomic instrument for Predictive Product Quality Check in Autologous CAR-T Immunotherapies (5R44CA210841-06). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10151540. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*