Drug intelligence / Profile preview

GT101 + cyclophosphamide + fludarabine + interleukin-2

Development stage
Phase 1
Lead developer
Grit Biotechnology
Modality
Cell Therapies, Cytokines & Interferons → Recombinant Proteins and Enzymes, Small Molecules
Administration
Intravenous
01

Overview

GT101 + cyclophosphamide + fludarabine + interleukin-2 is a combination immunotherapy regimen centered on GT101, an autologous, non-gene-engineered tumor-infiltrating lymphocyte (TIL) therapy developed by Suzhou Gravel Biotechnology. The treatment protocol involves a lymphodepleting conditioning phase using the "FC regimen" (cyclophosphamide and fludarabine) to deplete host lymphocytes and facilitate the engraftment of the infused cells. Following lymphodepletion, ex vivo expanded GT101 cells are reinfused into the patient, followed by the administration of high-dose interleukin-2 (IL-2) to promote the expansion and persistence of the TILs in vivo. This regimen is currently in pivotal Phase 2 clinical trials in China, primarily targeting metastatic cervical carcinoma and other advanced solid tumors.

Other names
GT-101 + FC + IL-2
02

Targets

DNADNA polymerase familyIL-2R (Interleukin-2/interleukin-15 receptor complex)RNR (Ribonucleotide reductase)

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