Chinese biotechnology company CARsgen has finished enrolling subjects in its Phase II trial of satri-cel, a potential first-in-class CAR T-cell therapy for advanced gastric cancer, in China.
The trial is evaluating the efficacy and safety of satri-cel in treating patients with advanced gastric/gastroesophageal junction cancers (GC/GEJ) who have exhausted other treatment options.
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Satri-cel is a Claudin18.2 CAR T-cell therapy that targets Claudin18.2, a protein frequently found in GC/GEJ and pancreatic cancer cells.
The open-label, multicentre, randomised study will compare the effects of satri-cel against those of standard therapies chosen by physicians, including paclitaxel, docetaxel, irinotecan, apatinib and nivolumab.
CARsgen Therapeutics founder, board chairman, CEO and chief scientific officer Dr Zonghai Li said: “We are very pleased to announce the successful completion of patient enrolment in the pivotal Phase II clinical trial of satri-cel in China.
“This significant milestone marks another solid step forward in our development of CAR T-cell therapies for solid tumours.
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By GlobalData“We look forward to the submission of a new drug application and approval in China to benefit patients with gastric cancer.”
Satri-cel has previously demonstrated promising results in early-stage clinical evaluations.
In the Phase I CT041-CG4006 trial, the drug was reported to be well-tolerated, with no reports of dose-limiting toxicities, severe cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome.
The efficacy data from the same trial showed an overall response rate of 54.9% among 51 GC/GEJ patients treated with satri-cel, with a 96.1% disease control rate and a median response duration of 6.4 months.
Phase Ib results from the CT041-ST-01 trial showed overall response and disease control rates of 57.1% and 78.6% respectively among GC/GEJ patients who had previously undergone at least two lines of therapy.
Ongoing trials for Satri-cel include the investigator-initiated trials CT041-CG4006 and NCT03874897, as well as a confirmatory Phase II clinical trial for advanced GC/GEJ in China.
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