Drug intelligence / Profile preview

nolgileucel + PD-1 antibody

Development stage
Unknown
Lead developer
Shanghai Juncell Therapeutics
Modality
Cell Therapies, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

GC101 TIL + PD-1 antibody (also known as nolgileucel plus PD-1 blockade) is an investigational combination immunotherapy developed by Juncell Therapeutics (Shanghai Junsai Biological Technology). The regimen combines GC101 (nolgileucel), an autologous tumor-infiltrating lymphocyte (TIL) cell therapy, with a PD-1 checkpoint inhibitor antibody (such as sintilimab or pembrolizumab). GC101 is designed as a next-generation TIL therapy that does not require high-intensity lymphodepletion chemotherapy or high-dose interleukin-2 (IL-2) administration, significantly improving safety and tolerability. The combination is being evaluated in Phase II clinical trials (including the MIZAR-003 study) for advanced solid tumors, including PD-1-refractory advanced melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and MSI-H/dMMR tumors.

Other names
GC101 + pembrolizumabGC101 + sintilimabGC101 TIL + PD-1 antibodyGC101 TIL plus PD-1 blockadeGC-101 TIL plus PD-1 blockadeGC 101 TIL plus PD-1 blockadenolgileucel + PD-1 antibodynolgileucel + pembrolizumabnolgileucel + sintilimab
02

Targets

pMHC-II (Peptide-major histocompatibility complex class II complex)

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