CARsgen Finishes Enrolling Patients in Pivotal Trial in China for Gastric/Gastroesophageal CAR-T Satri-Cel

CARsgen has completed the enrollment of patients in its pivotal phase 2 clinical trial (NCT04581473) evaluating satricabtagene autoleucel (satri-cel; CT041), an investigational chimeric antigen receptor T-cell (CAR-T) therapy that targets CLDN18.2, for the treatment of CLDN18.2-positive advanced gastric/gastroesophageal (GC/GEJ) cancer.¹

The open-label, multicenter, and randomized trial, which is taking place in China, is assessing satri-cel against a control group, in which patients will be treated with either paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab, according to the judgement of the treating physician. The study was open to patients with advanced GC/GEJ whose disease was not successfully treated with 2 or more previous lines of therapy.

“We are very pleased to announce the successful completion of patient enrollment in the pivotal phase 2 clinical trial of satri-cel in China,” Zonghai Li, MD, PhD, the founder, chairman of the board, CEO, and chief scientific officer of CARsgen Therapeutics, said in a statement.¹ “This significant milestone marks another solid step forward in our development of CAR T-cell therapies for solid tumors. We extend our gratitude to all the investigators, the patients and their families for their trust and support. We look forward to the submission of a New Drug Application and the approval in China, to benefit patients with gastric cancer. As one of the leading companies in the field of CAR T-cell therapies, we remain committed to addressing the major challenges faced by existing CAR T-cell therapies and will develop more innovative CAR-T products for cancer patients.”

Satri-cel was previously evaluated in an investigator initiated phase 1 clinical trial (CT041-CG4006; NCT03874897), results from which were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 to June 4, in Chicago, Illinois. According to CARsgen, in 51 patients who were treated with satri-cel as a monotherapy in the trial who had GC/GEJ with target lesions at baseline, 28 patients achieved a response (54.9% overall response rate). Furthermore, the group showed a disease control rate of 96.1% (49/51) and a median duration of response of 6.4 months. In terms of safety, CARsgen pointed out that there were no dose-limiting toxicities, no cases of cytokine release syndrome assessed as grade 3 or higher, and no cases of immune effector cell-associated neurotoxicity syndrome.

In the United States, satri-cel is being evaluated in the phase 1b ELIMYN18.2 clinical trial (NCT04404595) in patients with heavily pretreated CLDN18.2-positive advanced GC/GEJ or pancreatic cancer (PC).² Data from cohort A of this trial were presented in a poster earlier this year at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers (GI) Symposium, held January 18-20, in San Francisco, California. Objective response rate was 42.9% (n = 3) in GC/GEJ, 16.7% (n = 2) in PC, and 42.9% overall at dose level 3 (DL3, 600x10⁶, n = 7), which was selected as the recommended phase 2 dose (RP2D). There was 1 complete response (CR) in GC/GEJ in DL3, 2 partial responses (PRs) in GC/GEJ, and 2 PRs in PC in DL3.

“Satri-cel’s, the first autologous CLDN18.2 CAR T cell therapy, safety profile was encouraging, with manageable treatment-related adverse events,” poster author Gregory P. Botta, MD, PhD, associate professor of medicine, University of California San Diego, and colleagues, wrote.¹ “Initial efficacy was promising in heavily pretreated CLDN18.2-positive advanced GC/GEJ and PC population and consistent with earlier reports.”

REFERENCES
1. CARsgen announces enrollment completion in China GC/GEJ pivotal phase II clinical trial of the first-in-class Claudin18.2 CAR T (satri-cel). News release.CARsgen Therapeutics Holdings Limited. August 19, 2024. Accessed August 23, 2024. https://www.carsgen.com/en/news/20240819/
2. Botta GP, Kelly RJ, Jin Z, et al. CLDN18.2 chimeric antigen receptor T cell therapy for patients with advanced gastric and pancreatic adenocarcinoma: Results of ELIMYN18.2 phase 1b clinical trial. Presented at: 2024 ASCO GI; January 18-20; San Francisco, California. Abstract #356