China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the presentation of interim results from the Phase Ib ELIMYN18.2 study’s dosage escalation phase for its pipeline asset, CT041. The data will be showcased at the esteemed 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI 2024). The study is evaluating the safety and efficacy of CT041 in patients with advanced gastric cancer/esophageal gastric junction adenocarcinoma (GC/GEJ) or pancreatic cancer (PC), who are receiving second-line therapy.
CT041, a potential first-in-class CAR-T cell therapy targeting CLDN18.2, is being investigated in a single-arm, open-label Phase Ib/II study for patients with CLDN18.2-positive tumors. As of September 15, 2023, with a median follow-up time of 8.9 months, CT041 has demonstrated a favorable safety profile. There have been no cases of hemophagocytic lymphohistiocytosis (HLH), dose-limiting toxicity (DLT), or treatment-related deaths. The majority of cytokine release syndrome (CRS) cases were grade 1, with three cases of grade 2 CRS and two cases of grade 3 CRS. One patient experienced grade 1 immune effector cell-related neurotoxicity syndrome (ICANS), and all CRS and ICANS events have resolved.
The Phase Ib study results led to the selection of DL3 (600 × 106 cells) as the recommended Phase II dose (RP2D). The confirmed objective response rate (ORR) for GC/GEJ patients across all dose groups was 42.9% (3/7). The clinical benefit rate (CBR) for GC/GEJ or PC patients in DL3 was 71.4% (5/7), with one GC/GEJ patient achieving complete remission.- Flcube.com
