Overview

NCI Definition [1]:
A preparation of genetically modified autologous lymphocytes comprised of CD62L-positive naïve and memory T-cells (Tn/mem), that are transduced ex vivo with a self-inactivating (SIN) lentiviral vector expressing a hinge-optimized chimeric antigen receptor (CAR) specific for the CD19 antigen and containing CD28 and CD3 zeta signaling domains, and a truncated form of the human epidermal growth factor receptor (EGFRt), with potential immunostimulating and antineoplastic activities. Upon isolation of peripheral blood lymphocytes (PBLs), transduction of the CD62L-positive T-lymphocytes, expansion ex vivo and reintroduction of the cells into the patient, the autologous CD19R(EQ)-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-cells target CD19-expressing tumor cells, thereby inducing selective toxicity in CD19-expressing tumor cells. CD19 antigen is a B-cell specific cell surface antigen expressed in all B-cell lineage malignancies. Devoid of both ligand binding domains and tyrosine kinase activity, EGFRt both facilitates in vivo detection of the administered T-cells and can promote elimination of those cells upon a cetuximab-induced antibody dependent cellular cytotoxicity response. Tn/mem T-cells include naïve T-cells, central memory T-cells (Tcm) and stem cell memory T-cells (Tscm). CD19R(EQ) contains two point mutations in the immunoglobulin (Ig) G4 spacer region, thereby preventing recognition of the CAR by Fc receptors (FcRs).

Cd19car-cd28-cd3zeta-egfrt-expressing tn/mem-enriched t-lymphocytes has been investigated in 4 clinical trials, of which 4 are open and 0 are closed. Of the trials investigating cd19car-cd28-cd3zeta-egfrt-expressing tn/mem-enriched t-lymphocytes, 3 are phase 1 (3 open) and 1 is phase 2 (1 open).

CD19 Expression, ERBB2 Amplification, and HER2 Overexpression are the most frequent biomarker inclusion criteria for cd19car-cd28-cd3zeta-egfrt-expressing tn/mem-enriched t-lymphocytes clinical trials.

Mantle cell lymphoma, acute lymphoblastic leukemia, and B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical hodgkin lymphoma are the most common diseases being investigated in cd19car-cd28-cd3zeta-egfrt-expressing tn/mem-enriched t-lymphocytes clinical trials [2].

Top Biomarker Inclusion Criteria for Open Clinical Trials Investigating Cd19car-Cd28-Cd3zeta-Egfrt-Expressing Tn/mem-Enriched T-Lymphocytes
This graph displays the 20 most frequently occurring biomarkers curated on clinical trials investigating cd19car-cd28-cd3zeta-egfrt-expressing tn/mem-enriched t-lymphocytes and the cancer types associated with these biomarkers. These numbers are derived from a set of 5,956 clinical trials for which biomarker status defines treatment.

Drug Details

Synonyms [2]:
cd19r(eq)28zetaegfrt+ tn/tmem, cd19r(eq)28zetaegfrt+ tn/mem cells, cd19r(eq)28zetaegfrt+ tn/mem cells, autologous cd19car-cd28-cd3zeta-egfrt-expressing tn/mem-enriched t-lymphocytes, d19car-cd28-cd3zeta-egfrt-expressing tn/mem-enriched t-lymphocytes, cd19r(eq)28zeta/egfrt+ naive and memory t cells, cd19car-cd28-cd3zeta-egfrt-expressing tn/mem-enriched t cells
Drug Target(s) [2]:
CD19
NCIT ID [1]:
C133073

References

1. National Cancer Institute. NCI Thesaurus Version 18.11d. https://ncit.nci.nih.gov/ncitbrowser/. [2018-07-30] [2018-08-02].

2. All assertions and clinical trial landscape data are curated from primary sources. You can read more about the curation process here.