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NeoTCR-P1

Development stage
Phase 1
Lead developer
PACT Pharma
Modality
CRISPR-Cas9 → CRISPR Systems → Programmable Nucleases → Gene Editing → Gene Therapies, Recombinant Proteins and Enzymes, Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

NeoTCR-P1 is a fully personalized, autologous adoptive T cell therapy designed for the treatment of solid tumors. It involves isolating and engineering a patient’s own CD8 and CD4 T cells to express a unique, native-sequence T cell receptor (TCR) that specifically targets neoepitopes—mutated peptides presented by human leukocyte antigen (HLA) molecules—found exclusively on the patient’s tumor cells. The therapy uses precision genome engineering to replace endogenous TCR genes with those encoding the tumor-specific neoTCRs identified from each individual patient. This process does not use viral vectors but instead relies on non-viral gene editing methods such as CRISPR. Upon infusion back into the patient following conditioning chemotherapy, these engineered cells are intended to recognize and kill cancer cells bearing the targeted mutation while sparing normal tissues. The approach is being evaluated in Phase 1 clinical trials both as monotherapy and in combination with anti–PD-1 therapy (nivolumab), primarily for patients with advanced or metastatic solid tumors who have exhausted standard therapies[1][2][3][4][5][6][7][8].

Other names
gene-edited autologous neoantigen-targeted NeoTCR-P1 T cellsAutologous gene-edited TCR T cell product - PACT Pharma
02

Targets

Patient-specific neoantigenic peptide presented by autologous human leukocyte antigen (HLA)

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