Kailimei (satricabtagene autoleucel) / CARsgen - LARVOL DELTA

Barriers and Blueprints: Next-Generation Engineering Strategies for CAR-T Cell Therapy in Gastrointestinal Tumors. (PubMed, Pharmaceuticals (Basel)) - "Rather than relying on a single technological advance, the future of CAR-based therapy for GI malignancies will likely depend on integrating multiple engineering approaches to address the diverse biological barriers within the tumor microenvironment. By synthesizing current preclinical and early clinical evidence, this review provides a translational framework for the next generation of CAR-based cellular therapies in gastrointestinal oncology."

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

Current and Emerging Targeted Therapy in Advanced Gastroesophageal Adenocarcinoma. (PubMed, Pharmaceuticals (Basel)) - " HER2-directed therapy has progressed from trastuzumab through dual blockade, immunotherapy combinations, next-generation ADCs (notably trastuzumab deruxtecan) and bispecific antibodies such as zanidatamab, which has now overtaken trastuzumab in the first-line setting. CLDN18.2-targeted zolbetuximab has demonstrated survival benefit in biomarker-selected patients, with newer ADCs, BiTEs and the first approved solid-tumour CAR-T therapy (satricabtagene autoleucel) extending this target further. VEGFR2 inhibition with ramucirumab remains a cornerstone in later lines, while novel VEGF/PD-1(L1) bispecifics are under investigation. FGFR2b-targeted bemarituzumab showed early promise that weakened on phase 3 confirmation, and MET/EGFR-directed agents, including savolitinib and amivantamab, require stringent biomarker selection to demonstrate benefit amid tumour heterogeneity. Novel targeted agents, particularly to HER2 and CLDN18.2, have demonstrated survival benefit despite..."

IO biomarker • Journal • Review • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Satricabtagene autoleucel (satri-cel) as consolidation therapy following adjuvant treatment for locally advanced gastric or gastroesophageal junction cancer (G/GEJC): preliminary results from a phase Ib trial (ESMO 2026) - No abstract available

Clinical • Metastases • P1 data • Gastric Cancer • Oncology • Solid Tumor

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

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

Multicenter phase Ib trial in the U.S. of salvage CT041 CLDN18.2-specific chimeric antigen receptor T-cell therapy for patients with advanced gastric and pancreatic adenocarcinoma. (ASCO 2022) - P1, P1b | "All patients completed a conditioning regimen consisting of fludarabine, cyclophosphamide, and nab-paclitaxel prior to CT041 CAR T cells...Only one patient received tocilizumab... These preliminary results indicate that CT041 therapy was safe and had therapeutic efficacy in patients with advanced GI cancers. In heavily pre-treated gastric cancer, CT041 may have significantly improved anti-tumor activity compared to historical treatment regimens."

CAR T-Cell Therapy • Clinical • P1 data • CNS Disorders • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Inflammation • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CLDN18

Beyond Zolbetuximab: Next-Generation Targeting Strategies for CLDN18.2. (PubMed, J Gastrointest Cancer) - "Tissue immunohistochemistry remains the reference method for treatment selection; circulating tumor DNA cannot currently reproduce membranous protein intensity or spatial distribution, and liquid-biopsy approaches for CLDN18.2 reassessment remain investigational."

Journal • Review • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Oncology • Solid Tumor • CLDN18

Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial interim results. (PubMed, Nat Med) - P1 | "In patients with GC, the ORR and DCR reached 57.1% and 75.0%, respectively, and the 6-month overall survival rate was 81.2%. These initial results suggest that CT041 has promising efficacy with an acceptable safety profile in patients with heavily pretreated, CLDN18.2-positive digestive system cancers, particularly in those with GC."

CAR T-Cell Therapy • Journal • P1 data • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Inflammation • Oncology • Solid Tumor • CLDN18 • CLDN8

Safety, tolerability, and preliminary efficacy results in patients with advanced gastric/gastroesophageal junction adenocarcinoma from a phase Ib/II study of CLDN18.2 CAR T-cell therapy (CT041). (ASCO 2022) - P1/2 | "These preliminary results suggest that CT041 had manageable safety/tolerability profile and promising efficacy in patients with previously treated advanced G/GEJ cancer. This study is ongoing with further investigation of CT041 in phase II underway."

CAR T-Cell Therapy • Clinical • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Oncology • Solid Tumor • CLDN18 • CLDN8

Claudin18.2-targeted chimeric antigen receptor T cell-therapy for patients with gastrointestinal cancers: Final results of CT041-CG4006 phase 1 trial. (ASCO 2024) - P1 | "Satri-cel/CT041 demonstrated a promising safety profile and highly encouraging efficacy in heavily pretreated patients with CLDN18.2-positive advanced GI cancers."

CAR T-Cell Therapy • Clinical • P1 data • Biliary Cancer • Biliary Tract Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Safety and Efficacy of CT041 in Patients With Refractory Metastatic Pancreatic Cancer: A Pooled Analysis of Two Early-Phase Trials. (PubMed, J Clin Oncol) - "In patients with metastatic PC after progression on previous therapy, CT041 demonstrated a tolerable safety profile and encouraging anticancer efficacy signals. Response benefit observed here needs to be ascertained in the future."

Journal • Metastases • Retrospective data • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CA 19-9 • CLDN18

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

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

Engineering CAR-T cells for solid tumors: Overcoming the microenvironment through integrated design and clinical translation. (PubMed, Oncoscience) - "Beyond the local microenvironment, emerging recognition of systemic neuroendocrine-immune dysregulation further informs CAR-T persistence and fitness considerations. This review synthesizes the mechanistic insights, engineering strategies, clinical evidence, and emerging platforms, including in vivo lentiviral CAR-T generation, that define the current landscape, and proposes a tiered framework for next-generation solid tumor CAR-T development, while explicitly acknowledging the limitations and unknowns that persist."

IO biomarker • Journal • Review • Brain Cancer • Diffuse Midline Glioma • Gastric Cancer • Glioma • Hematological Malignancies • Hepatocellular Cancer • Oncology • Solid Tumor • CLDN18 • DNMT3A • GPC3 • IL10 • IL15 • JUN • TGFB1

Fosun Health launches world’s first approved solid tumor CAR-T therapy (Observer) - Fosun Hospital Guangzhou…has completed the cell collection procedure for the first gastric cancer patient receiving treatment with Kailimei (Satricabtagene Autoleucel Injection, R&D code: CT041) therapy pathway in the Greater Bay Area.

Launch non-US • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

First CAR T-Cell Therapy Approved for Solid Tumors. (PubMed, Cancer Discov) - "The approval stems from a phase II trial that found the cells increased progression-free survival and overall survival. Scientists are excited about the decision but caution that more research is necessary to improve the effectiveness of CAR T cells against solid tumors."

Journal • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

CARsgen Therapeutics…announces that the preliminary positive research results of IIT (CT041-CG4010, NCT06857786) in China of satricabtagene autoleucel…as consolidation therapy following adjuvant treatment for locally advanced gastric or gastroesophageal junction cancer, has been accepted for poster presentation at the…ESMO Congress 2026 (CARsgen Press Release) - "Since the initiation of patient enrollment in May 2025 for the CT041-CG4010 trial, up to the date of this press release, none of the participants receiving satri-cel have experienced postoperative recurrence or metastasis of gastric cancer."

P1 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma

Unveiling Biomarkers of Response and Resistance to Claudin18.2-targeted CAR-T Cell Therapy (CT041) in Gastric Cancer: A Phase 1 Biomarker Analyses (BSG 2026) - P1 | "Conclusion The biological significance and clinical implications of GZMK+ Tpex in determining response to CAR-T cell treatment of GC, and IQGAP3+CLDN18.2+ cancer cells as related to resistance were underscored, which were conducive to guiding patient selection for CT041 therapy and offered insights into resistance mechanisms. Download figure Open in new tab Download powerpoint Abstract O15 Figure 1 Overview of the study design and the schematic summary of systemic and local immunity mediating response and resistance to Claudin18.2-specific CAR-T cell therapy in gastric cancer"

Biomarker • CAR T-Cell Therapy • IO biomarker • P1 data • Gastric Cancer • Oncology • Solid Tumor • CD8 • CLDN18 • GZMK • IFNG • IL6 • IRF8 • TGFB1

Shanghai SinoUnited Hospital…announced the availability of satricabtagene autoleucel ("satri-cel")…approved for the treatment of solid tumor s, for eligible patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have failed at least two prior lines of therapy. (The Manila Times) - "Clinical evidence from the pivotal CT041-ST-01 randomized controlled trial demonstrated meaningful efficacy in heavily pretreated patients."

Launch non-US • Gastroesophageal Junction Adenocarcinoma

Long-term control of peritoneal metastases following claudin 18.2-targeted CAR T-Cell therapy in advanced gastric cancer. (PubMed, J Hematol Oncol) - P1 | "Although circulating CAR T-cells became nearly undetectable in peripheral blood by around day 30 after infusion, CAR T-cell infiltration was still detected in resected gastric or ovarian tumor tissues months later. These findings support substantial and durable activity of CLDN18.2 CAR T-cell therapy in gastric cancer with peritoneal metastasis."

Journal • Gastric Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18

CARsgen Announces Approval of Satri-cel, the World’s First CAR T-Cell Therapy Product for Solid Tumors (CARsgen Press Release) - "CARsgen...announced that as informed by the National Medical Products Administration ('NMPA') today, the New Drug Application ('NDA') of satricabtagene autoleucel ('satri-cel'), the proprietary autologous humanized Claudin18.2 CAR T-cell therapy product, was approved for the treatment of patients with Claudin18.2-positive, HER2-negative advanced gastric/ gastroesophageal junction adenocarcinoma (G/GEJA) who have failed at least two prior lines of therapy."

China approval • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER-2

Long-term follow-up of satricabtagene autoleucel (satri-cel) as sequential therapy after first-line treatment for advanced gastric cancer: A subgroup analysis. (ASCO 2026) - P1 | "Clinical Trial Registration Number: NCT03874897 Background: Claudin18.2 (CLDN18.2) has emerged as a new target for the treatment of gastric cancer in the first-line (1L) setting with the approval of zolbetuximab... With an extended follow-up exceeding 4.5 years, satri-cel as first-line sequential treatment continues to demonstrate durable survival benefit with a manageable safety profile in patients with advanced G/GEJ cancer, supporting its highly promising potential in earlier lines of therapy."

Clinical • Metastases • Febrile Neutropenia • Gastric Cancer • Infectious Disease • Neutropenia • Oncology • Solid Tumor • CLDN18

Long-term Follow-up Results of CARsgen's Satri-cel as Sequential Therapy After First-Line Treatment for Gastric Cancer Presented at the 2026 ASCO Annual Meeting (PRNewswire) - "The 2026 ASCO Annual Meeting features the long-term follow-up results of Cohort 3 from this study, with a follow-up duration exceeding 4.5 years. In this cohort, 5 patients with Claudin18.2-positive gastric/gastroesophageal junction (G/GEJ) cancer received satri-cel infusion at a dose of 2.50×10⁸ cells sequentially after 1L therapy....As of October 18, 2025, the median follow-up of the 5 patients from initial 1L therapy was 54.6 months. Among the 4 patients with target lesions, the confirmed objective response rate (ORR) was 100%....Among the 5 patients, the median progression-free survival (PFS) since 1L therapy was 20.9 months. Among these, 2 patients, with significant clinical benefit, underwent surgical resection after satri-cel therapy."

P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Extracellular vesicle glycosylation profilepredictsand affectstherapeutic outcomes ofCLDN18.2-targeted CAR-T cell therapyagainst gastrointestinal cancers (AACR 2026) - "Mechanistically, decreasing the level of GalNAc on the surface of EVs and tumor cells could strengthen killing capability of CAR-T cells in vitro. Collectively, our work provided novel biomarkers for GIC patients undergoing CLDN18.2 CAR-T cell therapy in view of plasma EV glycosylation and revealed the potential mechanism by which the EV glycosylation affects the efficacy of CAR-T therapy."

CAR T-Cell Therapy • IO biomarker • Gastrointestinal Cancer • Oncology • Solid Tumor • CD8 • CLDN18

Exploring the resistant mechanism of CAR T cell therapy targeting CLDN18.2 by single-cell sequencing (AACR 2024) - P1 | "Furthermore, we discovered that the high expression of CLDN18 in the ascites epithelial cells was correlated with a favorable prognosis, while ascites epithelial cells showing high MYC expression and the strong interaction between tumor cells and T cells were identified as adverse prognostic factors for CT041 treatment. These findings may provide theoretical evidence for subsequent screening of CAR T cell therapy benefitable population and improving the efficacy of CAR T cell therapy."

CAR T-Cell Therapy • Hematological Malignancies • Oncology • Solid Tumor • CLDN18 • MYC