satricabtagene autoleucel (CT041) / CARsgen - LARVOL DELTA

Modeling and addressing on-target/off-tumor toxicity of claudin 18.2 targeted immunotherapies. (PubMed, Nat Commun) - "However, GI toxicities are reported from clinical use of both Zolbetuximab and CT041...We also demonstrate and characterize on-target/off-tumor gastric toxicity targeting CLDN18.2 in a preclinical mouse model of CT041-scFv derived CAR T cell therapy. By developing CLDN18.2 fully-human VH-only single domain CARs, we demonstrate that on-target/off-tumor toxicity inversely correlates with affinity of the binder, and that a lower affinity CAR may widen the therapeutic window for CLDN18.2 by decreasing on-target/off-tumor toxicity while preserving efficacy."

IO biomarker • Journal • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Adjuvant therapy with claudin18.2-specific CAR T cells in high-risk pancreatic cancer (CT041-ST-05) (ESMO 2025) - P1 | "All pts developed cytokine release syndrome (grade 1 or 2) following the first infusion. Conclusions In this preliminary analysis with a limited sample size, satri-cel showed promising efficacy signals as adjuvant therapy for PDAC pts, evidenced by significant reductions in CA19-9 levels in the majority of pts and encouraging long-term survival trends."

CAR T-Cell Therapy • Clinical • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9 • CLDN18

CARsgen Presents Preliminary Results on Satri-cel for Adjuvant Therapy of Pancreatic Cancer at ESMO Congress 2025 (PRNewswire) - "With a median follow-up of 6.05 months from infusion, only one patient experienced disease recurrence, while others are still under disease free. The median disease-free survival (DFS) and median overall survival (OS) were not reached (NR). The 9-month DFS rate from surgery was 83.3%. Notably, one patient who has completed 52-week follow-up post infusion is still under follow-up without disease recurrence."

P1 data • Pancreatic Cancer

Improving Therapeutic Window of Claudin 18.2-Targeted CAR-T cells in Pancreatic Cancer Free (AACRPanCa 2025) - "A primary challenge to extending immunotherapies to solid tumors is selecting antigens with widespread tumor expression, but limited expression in normal tissues. 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 and share a novel design of CAR-T for targeting CLND18.2 in pancreatic cancer."

CAR T-Cell Therapy • IO biomarker • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

To Evaluate the Efficacy of CT041 in Sequential Treatment After First-line Treatment of Advanced Gastric/Esophagogastric Junction Adenocarcinoma (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Beijing GoBroad Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

To Evaluate the Efficacy of CT041 in Sequential Treatment After First-line Treatment of Advanced Gastric/Esophagogastric Junction Adenocarcinoma (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: Beijing GoBroad Hospital

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

Novel Therapies in Advanced Pancreatic Cancer: A Peak Beyond the Realms of Gene Targeting. (PubMed, Cureus) - "In patients with resectable and borderline resectable pancreatic cancer, both neoadjuvant/perioperative mFOLFIRINOX and gemcitabine-nab-paclitaxel (GEM-Abraxane) have shown comparable median overall survival (~23-25 months) and R0 resection rates (~64-80%) in the SWOG S1505 trial...The efficacy of novel agents targeting specific molecular pathways, including CLDN18.2 and PDGFRα, is currently being evaluated in early-phase trials (e.g., CT041, IMAB362)...While pancreatic cancer remains a formidable adversary, recent advancements in therapeutic strategies offer hope for improving patient outcomes by leveraging cutting-edge technologies and fostering collaborative research endeavors. This literature review focuses on the latest clinical trial results of novel therapies that have emerged for the management of pancreatic cancer."

IO biomarker • Journal • Review • Oncology • Pancreatic Cancer • Solid Tumor • BRCA1 • BRCA2 • CLDN18 • KRAS • MSLN • NRG1 • PALB2 • PDGFRA

ABSTRACT OF RESEARCH RESULTS ON SATRI-CEL FOR ADJUVANT THERAPY OF PANCREATIC CANCER ACCEPTED FOR POSTER PRESENTATION AT ESMO CONGRESS 2025 (HKEXnews) - "The board of directors of the Company (the 'Board') announces that the preliminary results of the Phase Ib registrational clinical trial of satricabtagene autoleucel ('satri-cel', CT041) (an autologous CAR T-cell product candidate against protein Claudin18.2) for pancreatic cancer (PC) adjuvant therapy in China (CT041-ST-05, NCT05911217) has been accepted for poster presentation at European Society for Medical Oncology (ESMO) Congress 2025. Abstract will be released at 00:05 CEST on Monday, October 13, 2025 on the ESMO official website."

P1 data • Pancreatic 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 I clinical trial (ESMO-GI 2025) - P1 | "Our study 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."

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

CARsgen Therapeutics Announces NDA Acceptance of Satri-cel by China's NMPA (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announces that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for 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. The NDA submission is mainly based on the results of an open-label, multicenter, randomized controlled confirmatory Phase II clinical trial (CT041-ST-01, NCT04581473) conducted in China."

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

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

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