# Phase 1/2 Clinical Study of Humanized Anti-BCMA CAR T Cells in Relapsed/Refractory Multiple Myeloma (MM)

> **NIH NIH R44** · CARTESIAN THERAPEUTICS, INC. · 2020 · $988,226

## Abstract

ABSTRACT
Multiple myeloma (MM) claims over 80,000 lives globally each year. Although several new therapies have been
approved over the past decade, virtually all patients relapse, and the median survival remains at only 5 years.
The depth of therapeutic response correlates with time to relapse, and eradicating tumor cells early in the disease
process may be necessary to achieve clinical cure. A potentially curative approach is autologous cell therapy
with chimeric antigen receptor (CAR) T-cells redirected to a target antigen. For MM, an attractive target antigen
is B cell maturation antigen (BCMA), an antigen marker with extremely high sensitivity and specificity for
myeloma and plasma cells. Experiments described in this SBIR proposal cover early-stage clinical research
(Phase I/II Clinical Trial) of an autologous anti-BCMA CAR T-cell product generated with mRNA (Descartes-11)
in order to overcome the toxicities associated with permanently modified CAR T-cells. The goals of the Specific
Aims are to 1) determine the safety, tolerability and Maximum Tolerated Dose of Descartes-11 in patients with
relapsed/refractory MM; 2) establish preliminary clinical benefit of Descartes-11 at MTD in relapsed/refractory
MM; 3) define correlative biomarkers of safety and efficacy in Descartes-11-treated patients. Use of mRNA to
generate Descartes-11 enables predictable pharmacokinetics, providing the prospect of controlled CAR T-cell
treatment of MM early in the course of the disease.

## Key facts

- **NIH application ID:** 10010096
- **Project number:** 2R44CA221432-02A1
- **Recipient organization:** CARTESIAN THERAPEUTICS, INC.
- **Principal Investigator:** Charles Andrew Stewart
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $988,226
- **Award type:** 2
- **Project period:** 2018-08-01 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10010096

## Citation

> US National Institutes of Health, RePORTER application 10010096, Phase 1/2 Clinical Study of Humanized Anti-BCMA CAR T Cells in Relapsed/Refractory Multiple Myeloma (MM) (2R44CA221432-02A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10010096. Licensed CC0.

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