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MDX3001

Development stage
Preclinical
Lead developer
ModeX Therapeutics
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Gene Therapies
Administration
Intravenous
01

Overview

MDX3001 is an investigational *in vivo* Chimeric Antigen Receptor (CAR) T cell therapy being developed by ModeX Therapeutics, a subsidiary of OPKO Health. Unlike traditional CAR T therapies that require complex *ex vivo* cell manufacturing—where patient cells are harvested, genetically modified in a lab, and then re-infused—MDX3001 is designed to program T cells directly within the patient's body. This approach utilizes gene-based delivery vectors, potentially mRNA or DNA, to introduce CAR constructs into endogenous T cells. The therapy is intended for the treatment of solid tumors, hematologic malignancies (blood cancers), and autoimmune conditions. By bypassing the need for external manufacturing, MDX3001 aims to reduce treatment costs, logistical complexity, and the time patients must wait for therapy. The program is currently in the IND-enabling stage of development.

Other names
CD3xCD28 bispecific antibody-conjugated lipid nanoparticle with CD19-CAR mRNACD-3xCD28 bispecific antibody-conjugated lipid nanoparticle with CD19-CAR mRNACD 3xCD28 bispecific antibody-conjugated lipid nanoparticle with CD19-CAR mRNACD3xCD28-targeted LNPs delivering CD19-CAR mRNACD-3xCD28-targeted LNPs delivering CD19-CAR mRNACD 3xCD28-targeted LNPs delivering CD19-CAR mRNA
02

Targets

CD3 (T-cell surface glycoprotein CD3)CD19 (B lymphocyte antigen CD19)CD28 (Cluster of Differentiation 28)

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