^
    1d
    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 | Trial completion date: Mar 2028 --> Aug 2028
    Trial completion date • First-in-human
    |
    pumitamig (BNT327)
    29d
    Efficacy and immunomodulatory effect of Claudin18.2-specific IL-7/XCL1 armored CAR-T cells in digestive tract cancer: preclinical and clinical analysis. (PubMed, Signal Transduct Target Ther)
    Taken together, present data demonstrate the therapeutic efficacy and safety of RD07 in our study and highlight its ability to both exert antitumor effects and remodel the TME. These findings support RD07 as an innovative CAR-T cell therapy for DTC.
    Preclinical • Journal • IO biomarker
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    CLDN18 (Claudin 18) • IL7 (Interleukin 7)
    |
    CLDN18.2 expression
    2ms
    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
    |
    CLDN18 (Claudin 18)
    2ms
    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
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CA 19-9 (Cancer antigen 19-9)
    4ms
    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
    5ms
    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
    5ms
    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
    |
    CLDN18 (Claudin 18)
    |
    Vyloy (zolbetuximab-clzb) • satricabtagene autoleucel (CT041)
    6ms
    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
    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, Recruiting, Beijing GoBroad Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    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, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
    |
    pumitamig (BNT327)
    7ms
    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)
    7ms
    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)