satricabtagene autoleucel (CT041) / CARsgen - LARVOL DELTA

Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial. (PubMed, Lancet) - P1/2 | "This is the first randomised controlled trial of CAR T-cell therapy in solid tumours globally. Satri-cel treatment resulted in a significant improvement in progression-free survival, with a manageable safety profile. These results support satri-cel as a new third-line treatment for advanced gastric or gastro-oesophageal junction cancer patients."

Journal • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

CT041-ST-01: Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection (clinicaltrials.gov) - P1/2 | N=192 | Active, not recruiting | Sponsor: CARsgen Therapeutics Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2024 ➔ Oct 2024

Enrollment closed • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • HER-2

Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01). (ASCO 2025) - P1/2 | "For TPC arm, one of the standard of care (SOC) drugs (apatinib, paclitaxel, docetaxel, irinotecan or nivolumab) was given per physician's decision... This is the first confirmatory RCT of CAR T-therapy in solid tumors. Satri-cel demonstrated significant PFS improvement and an obvious OS benefit with a manageable safety profile. These results support satri-cel as a potential new SOC for advanced G/GEJC."

CAR T-Cell Therapy • Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Decoding the response and resistant features to the Claudin18.2-specific CAR-T cell CT041 in gastric cancer: A multi-omics exploratory biomarker analysis of the phase 1 clinical trial. (ASCO 2025) - P1 | "This exploratory analysis first unveiled the biological underpinnings and clinical implications of GZMK+ Tpex in determining response and resistance to the Claudin18.2-specific CAR-T therapy."

Biomarker • CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Gastric Cancer • Oncology • Solid Tumor • CD8 • CLDN18 • CXCR4 • GZMK • IL6 • IRF8 • NR4A1

Experimental Drug Helped Cancer Patients Live 40% Longer in Clinical Trial (ScienceAlert) - P1b/2 | N=192 | NCT04581473 | Sponsor: CARsgen Therapeutics Co., Ltd. | "An innovative new treatment for tackling some of the toughest stomach cancers has shown promise in a phase 2 clinical trial, leading to noticeable improvements in tumor shrinkage and survival rates....This specific therapy is called satricabtagene autoleucel, or satri-cel, and it targets the CLDN18.2 protein that certain tumors can use to grow....The trial involved 156 participants with either gastric or gastroesophageal junction cancer, who hadn't responded to at least two existing treatments – essentially, people who were running out of options before the trial....In the satri-cel group, patients lived a median average of 7.92 months compared to 5.49 months in the control group. In 22 percent of satri-cel patients, there was significant tumor shrinkage, compared to just 4 percent of the control patients. The median time before the cancer worsened was 3.25 months with satri-cel, and 1.77 months without."

P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Satricabtagene Autoleucel Yields PFS and OS Benefit in Advanced Gastric and Gastroesophageal Junction Cancer (ASCO Daily News) - "Discussant Anwaar Saeed, MD...noted that this is one of the first randomized trials with CAR T cells in gastrointestinal malignancies and is giving the clinicians an idea of the potential of CAR T cells in this space and, in particular, of targeting CLDN18.2."

Media quote

CARsgen Presents Research Results on Satri-cel in The Lancet and at the 2025 ASCO Annual Meeting (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announces that the results of the pivotal Phase II clinical trial in China (CT041-ST-01, NCT04581473) investigating satricabtagene autoleucel ('satri-cel', CT041) (a Claudin18.2-specific autologous CAR T-cell product candidate) in patients with Claudin18.2-positive, advanced gastric/gastroesophageal junction cancer refractory to at least two prior lines of treatment, have been published in The Lancet and were orally presented at the 2025 ASCO Annual Meeting....The oral presentation at the 2025 ASCO Annual Meeting (Abstract 4003) was titled 'Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01)'....'The positive result of this randomized controlled trial marks a major milestone in solid tumor CAR-T therapy'."

P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

CARsgen's Satri-cel Granted Priority Review by the NMPA (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announces that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Priority Review to satricabtagene autoleucel ('satri-cel', CT041)(an autologous CAR T-cell product candidate against protein Claudin18.2), for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy."

Priority review • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01) (PRNewswire) - P2 | N=192 | NCT04581473 | Sponsor: CARsgen Therapeutics Co., Ltd | "In ITT population (i.e., all randomized patients), satri-cel arm showed significant improvement in mPFS by IRC (3.25m vs 1.77m; HR 0.366, 95% CI:0.241, 0.557; p < 0.0001) meeting the primary endpoint with a 63% reduction in risk of disease progression or death. Even with 15.4% (n=16) patients in satri-cel arm failing to receive infusion and nearly 40% (n=20) patients in TPC arm receiving subsequent satri-cel, satri-cel arm still demonstrated a clear trend toward OS benefit (mOS 7.92m vs 5.49m; HR 0.693, 95% CI: 0.457, 1.051; one-sided p = 0.0416) , showing over 30% reduction in mortality risk...Of particular note, 20 TPC patients with subsequent satri-cel infusion achieved an mOS of 9.20 months. When analyzing all 108 patients who received satri-cel infusion (88 patients in satri-cel arm and 20 patients in TPC arm), the mOS reached 9.17 months, while the mOS of 28 patients in..."

P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Modeling and Use of Engineering to Overcome On-Target/Off-Tumor Toxicity of Claudin 18.2-Targeted CAR-T cells in Gastric Cancer (ASGCT 2025) - "Claudin 18.2 (CLDN18) targeted therapies, such as monoclonal antibody, zolbetuximab, and CAR-T cell, Satri-cel (CT041) are expanding access to immunotherapy in gastric cancer, however, high rates of nausea and vomiting were seen...We demonstrate that appropriate modeling of anticipated toxicity and careful examination of binding kinetics is critical to engineering a CAR with an optimal therapeutic window. Disease Focus of Abstract:Cancer Solid Tumors"

CAR T-Cell Therapy • IO biomarker • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Graft versus Host Disease • Immunology • Oncology • Solid Tumor • CLDN18

Decoding the Responsive and Resistant Features to the Claudin18.2-specific CAR-T cell CT041 in Gastric Cancer: An Exploratory Biomarker Analysis of the Phase 1 Clinical Trial (CIMT 2025) - P1 | "This exploratory analysis has, for the first time, elucidated the biological significance and clinical implications of pre-existing GZMK+ Tpex in determining response to CAR-T cell treatment of GC, and IQGAP3+ cancer cells as related to resistance, which facilitate tailoring CT041 therapy for better efficacy."

Biomarker • CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Gastric Cancer • Oncology • Solid Tumor • CD8 • CLDN18 • GZMK • IFNG • IL6 • IRF8

CLDN18.2-Targeryed Satri-Cel Generates Activity in GI Cancer (OncLive) - P1 | N=134 | NCT03874897 | "Final results of the single-arm, open-label, phase 1 CT041-CG4006 trial (NCT03874897) published...revealed that the claudin18.2 (CLDN18.2)–directed autologous CAR T-cell therapy satri-cel was well tolerated and efficacious in patients with CLDN18.2-positive advanced gastrointestinal (GI) cancer.1 No dose-limiting toxicities (DLTs) or treatment-related deaths were reported, and the overall response rate (ORR) was 38.8% in patients treated with satri-cel (n = 98). Additionally, the disease control rate was 91.8%, the median progression-free survival (PFS) was 4.4 months (95% CI, 3.7-6.6), and the median overall survival (OS) was 8.8 months (95% CI, 7.1-10.2)."

P1 data • Gastrointestinal Cancer

Decoding the Responsive and Resistant Features to the Claudin18.2-specific CAR-T cell CT041 in Gastric Cancer: An Exploratory Biomarker Analysis of the Phase 1 Clinical Trial (ESMO-GI 2025) - No abstract available

Biomarker • CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Gastric Cancer • Oncology • Solid Tumor • CLDN18

CARsgen Announced 2024 Annual Results (PRNewswire) - "Satri-cel:...Plans to Submit an NDA:...CARsgen plans to submit an NDA to the NMPA in China during the first half of 2025. Satri-cel is expected to become the world's first CAR-T therapy for solid tumors to be approved for market."

China filing • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

CT041-CG4010: Postoperative Adjuvant Therapy for CT041 Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma Patients (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Peking University

New P1 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

CARsgen's Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announces that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to satricabtagene autoleucel ('satri-cel', CT041) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction cancer (G/GEJ) in patients who have failed at least two prior lines of therapy. The company plans to submit a New Drug Application (NDA) for satri-cel to the NMPA in the first half of 2025."

Breakthrough therapy • China filing • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Clinical efficacy of CAR-T therapy Satricabtagene autoleucel (CT041) in the treatment of CLDN18.2-positive gastric cancer [Google translation] (Sohu.com) - "On February 21, 2025, the official website of the Center for Drug Evaluation of the National Medical Products Administration (CDE) announced that CAR-T therapy Satricabtagene autoleucel injection (code name: CT041) developed by Coherus Pharmaceuticals targeting Claudin18.2 (CLDN18.2) is planned to be included in the breakthrough therapy category. The proposed indication is: for the treatment of patients with advanced gastric/esophageal gastric junction (G/GEJ) adenocarcinoma with positive Claudin18.2 expression who have failed at least two lines of treatment."

Breakthrough therapy • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Exploring the therapeutic efficacy difference in claudin18.2-targeted cell therapy revealed by single-cell sequencing. (PubMed, iScience) - P1 | "We found that high expression of CLDN18 in ascites epithelial cells correlated with a favorable prognosis, whereas ascites epithelial cells with high MYC expression and strong interactions between tumor cells and T cells were adverse prognostic factors for CT041 treatment. These findings may provide theoretical evidence for the screening of populations that can benefit from CAR T therapy and improve the efficacy of CAR T therapy."

Journal • Gastric Cancer • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • CLDN18 • MYC

Exploring the role of bispecific and CAR-T cell therapies in gastric cancer: A systematic review and meta-analysis. (ASCO-GI 2025) - "Bispecific antibodies were MCLA-128 (25/138), catumaxomab (15/138), AK104 PD-1/CTLA-4 (16/138), ABL 001 DLL4VEGFA (19/138), and KN026 (25/138) while CART therapy was CT041 (38/138)... This analysis shows promising results in GC patients using bi-specific antibodies and CAR-T cell therapy. However, further clinical trials are needed to fully explore their potential."

CAR T-Cell Therapy • Retrospective data • Review • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CTLA4 • PD-1

CARsgen Announces Positive Topline Results from China GC/GEJ Pivotal Phase II Clinical Trial of Claudin18.2 CAR-T (Satri-cel) (PRNewswire) - P1/2 | N=192 | NCT04581473 | Sponsor: CARsgen Therapeutics Co., Ltd. | "The primary endpoint of the trial is progression-free survival (PFS) assessed by the Independent Review Committee (IRC). The study met its primary endpoint of a statistically significant improvement in PFS assessed by IRC for patients treated with satri-cel infusion as compared to treatment of physician's choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). Previous data demonstrates that the safety profile of satricabtagene autoleucel was manageable....We anticipate submitting an NDA to the NMPA in the first half of 2025 and look forward to satri-cel becoming the world's first CAR-T product for solid tumors, bringing hope to more patients as soon as possible."

China filing • P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer

CARsgen U.S. Clinical Holds Lifted by FDA (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announces that the U.S. Food and Drug Administration ('FDA') lifted the clinical holds on clinical trials of zevorcabtagene autoleucel (zevor-cel, CT053, an autologous CAR-T product against BCMA), satricabtagene autoleucel (satri-cel, CT041, an autologous CAR-T product against Claudin18.2), and CT071 (an autologous CAR-T product against GPRC5D) in the United States."

FDA event • Hematological Malignancies • Oncology

CARsgen Submitted Application to Request Lifting Clinical Holds to FDA (CARsgen Press Release) - "CARsgen Therapeutics Holdings Limited...announces that the U.S. Food and Drug Administration ('FDA') recently did a follow-up inspection of the manufacturing site located in Durham, North Carolina. The inspection was positive, and no observation (Form 483) was issued. The Company has submitted the complete response letters to request lifting the clinical holds for zevorcabtagene autoleucel, satricabtagene autoleucel and CT071 to FDA on October 4, 2024. FDA is expected to respond within 30 calendar days."

FDA event • Oncology

Keji Pharmaceutical-B (2171.HK): CARsgen plans to list CT041 and submit an NDA in the first half of 2025 [Google translation] (FUTU) - "CT041 is a potential global first-of-its-kind autologous CAR-T candidate targeting CLDN 18.2...it is planned to submit an NDA to the NMPA in the first half of 2025....With CT053 and CT041 approved for listing, we expect the company's revenue for 2024-2026 to be 100 million yuan, 300 million yuan, and 700 million yuan, respectively."

China filing • Commercial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

Targeting Claudin-18.2 for cancer therapy: updates from 2024 ASCO annual meeting. (PubMed, J Hematol Oncol) - "At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, the final results of the phase 3 SPOTLIGHT trial were presented, demonstrating a significant survival benefit from the addition of the CLDN18.2-specific antibody zolbetuximab to chemotherapy in the first-line treatment of advanced gastroesophageal adenocarcinomas with ≥ 75% CLDN18.2 expression...In addition, several early-phase trials presented at ASCO 2024 investigate other CLDN18.2-targeting approaches in CLDN18.2-positive refractory advanced solid tumors, including the CLDN18.2-targeting antibody-drug conjugates LM-302 and IBI343, the bispecific anti-CLDN18.2/CD3 antibody IBI38, and the chimeric antigen receptor T cell therapy satricabtagene autoleucel. These novel approaches could potentially expand the benefit of CLDN18.2-targeting therapies to a broader range of tumor types and to tumors expressing lower levels of CLDN18.2."

Journal • Review • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

CARsgen Announces Enrollment Completion in China GC/GEJ Pivotal Phase II Clinical Trial of the First-in-class Claudin18.2 CAR T (Satri-cel) (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announces that the completion of enrollment in the pivotal Phase II clinical trial of satricabtagene autoleucel ('satri-cel', R&D code: CT041, an autologous CAR-T product candidate against Claudin18.2) in accordance with the clinical protocol, for advanced gastric/gastroesophageal junction cancers (GC/GEJ) in China. This study is an open-label, multicenter, randomized clinical trial in China evaluating the efficacy and safety of satri-cel in subjects with Claudin18.2-positive advanced GC/GEJ patients who have failed at least two prior lines of therapy. Treatment for the control group is physician's choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab)."

Enrollment closed • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma