^
    17d
    Exploratory Clinical Study of Claudin18.2-Targeted Activated DC and CAR-T Therapy in Advanced Pancreatic Cancer. (clinicaltrials.gov)
    P1, N=10, Recruiting, Hainan Cancer Hospital
    New P1 trial
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    CLDN18 (Claudin 18)
    29d
    Clinical Study of CBG131 CAR-T Cell Injection for the Treatment of CLDN18.2-Positive Advanced Gastric and Pancreatic Cancer (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, First Affiliated Hospital of Wenzhou Medical University
    New P1 trial • IO biomarker
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    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CA 19-9 (Cancer antigen 19-9)
    3ms
    LB1908-1001: Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1, N=56, Active, not recruiting, Legend Biotech USA Inc | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    LB1908
    4ms
    Preclinical development and a case report of a nanobody-based CLDN18.2 CAR-T IMC002 with reduced on-target off-tumor toxicity. (PubMed, Mol Cancer Ther)
    The highest non-severely toxic dose was 5×108 CAR-T cells/kg. In the clinical case report, we present a case with unresectable advanced gastric cancer achieved pathological complete response 10 months after IMC002 infusion and no signs of recurrence were indicated in subsequent clinical and radiological follow-ups. IMC002 shows effectiveness and safety in CLDN18.2-positive gastric and pancreatic cancer and its favorable profiles support further clinical development.
    Preclinical • Journal
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    IMC002
    4ms
    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.
    Journal • IO biomarker
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    CLDN18 (Claudin 18)
    |
    Vyloy (zolbetuximab-clzb) • satricabtagene autoleucel (CT041)
    5ms
    Mechanistic data-informed multiscale quantitative systems pharmacology modeling framework enables the clinical translation and efficacy assessment of CAR-T therapy in solid tumors. (PubMed, J Immunother Cancer)
    Our translational QSP platform offers an innovative pathway to integrate multiscale knowledge and inform clinical decision-making of novel solid tumor-targeting CAR-T therapies.
    Journal
    |
    CLDN18 (Claudin 18)
    |
    LB1908
    5ms
    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, Beijing GoBroad Hospital | Not yet recruiting --> Recruiting
    Enrollment open
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    satricabtagene autoleucel (CT041)
    5ms
    A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=375, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
    |
    pumitamig (BNT327)
    6ms
    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, Beijing GoBroad Hospital
    New trial
    |
    satricabtagene autoleucel (CT041)
    6ms
    A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=375, Not yet recruiting, BioNTech SE
    New P1/2 trial
    |
    pumitamig (BNT327)
    7ms
    Noninvasive in vivo tracking of SPIONs-labeled CLDN18.2-targeted CAR-T cells in gastric cancer via magnetic particle imaging. (PubMed, Transl Res)
    On the fifth day post-infusion, the MPI signal of SPIONs-labeled CAR-T cells was significantly higher in the tumor than that of labeled normal T cells. MPI combined with FMI successfully monitored the targeting of CLDN18.2-specific CAR-T cells in gastric cancer, potentially guiding the evaluation of CAR-T therapy combined with aPD-L1 immunotherapy.
    Preclinical • Journal
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    CLDN18 (Claudin 18)
    7ms
    Phase 1 Trial of AZD6422 in CLDN18.2+ GI Tumors (clinicaltrials.gov)
    P1, N=8, Completed, Peking University | Recruiting --> Completed | N=96 --> 8 | Trial completion date: Nov 2028 --> Jun 2025 | Trial primary completion date: Jun 2026 --> Jun 2025
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    CLDN18 (Claudin 18)
    |
    AZD6422