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    DRUG CLASS:

    Mesothelin-targeted CAR-T immunotherapy

    Related drugs:
    1m
    A Long-Term Follow-Up Basket Study for Participants Treated with SynKIR Chimeric Antigen Receptor (CAR) T Cell Product (clinicaltrials.gov)
    P=N/A, N=60, Not yet recruiting, Verismo Therapeutics
    New trial • Pan tumor
    |
    SynKIR-110
    2ms
    Long-Term Follow-Up Safety Study of Subjects Treated with SynKIR-110 in Cancer Studies (clinicaltrials.gov)
    P=N/A, N=0, Withdrawn, Verismo Therapeutics | N=100 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    SynKIR-110
    3ms
    EVEREST-2: a seamless phase 1/2 study of A2B694, a logic-gated Tmod CAR T-cell therapy, in patients with mesothelin-expressing solid tumors with human leukocyte antigen-A*02 loss of heterozygosity (SITC 2024)
    a May occur at any point in disease course. CRC, colorectal cancer; D, day; MESO, mesothelioma; NSCLC, non-small cell lung cancer; OVCA, ovarian cancer; PANC, pancreatic cancer; PCLD, preconditioning lymphodepletionDownload figure Open in new tab Download powerpoint Abstract 627 Figure 3 EVEREST-2 phase 1 dose escalation study design
    Clinical • P1/2 data • CAR T-Cell Therapy • IO biomarker
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin)
    |
    MSLN expression • HLA-A*02
    |
    Tempus HLA-LOH assay
    |
    Ovarian cancer CAR-T therapy
    3ms
    A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer (clinicaltrials.gov)
    P1, N=18, Recruiting, Memorial Sloan Kettering Cancer Center
    New P1 trial
    |
    ATA2271
    3ms
    AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients with Platinum Resistant Epithelial Ovarian Cancer (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Arsenal Biosciences, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    cyclophosphamide • AB-1015
    4ms
    SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma (clinicaltrials.gov)
    P1, N=42, Recruiting, Verismo Therapeutics | Trial completion date: Mar 2026 --> Dec 2027 | Trial primary completion date: Mar 2026 --> Dec 2027
    Trial completion date • Trial primary completion date • Metastases
    |
    MSLN (Mesothelin)
    |
    SynKIR-110
    5ms
    CAR T Cells in Mesothelin Expressing Cancers (clinicaltrials.gov)
    P1, N=54, Completed, University of Pennsylvania | Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Jul 2024 | Trial primary completion date: Mar 2025 --> Nov 2023
    Trial completion • Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    cyclophosphamide • TmMSTN-01
    5ms
    Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=30 --> 14
    Enrollment closed • Enrollment change • CAR T-Cell Therapy • Checkpoint inhibition
    |
    MSLN (Mesothelin)
    |
    cyclophosphamide • ATA2271
    6ms
    GPC3/Mesothelin-CAR-γδT Cells Against Cancers (clinicaltrials.gov)
    P1, N=30, Recruiting, Second Affiliated Hospital of Guangzhou Medical University | Not yet recruiting --> Recruiting | Trial completion date: Dec 2033 --> Dec 2036 | Initiation date: Jan 2024 --> May 2024 | Trial primary completion date: Nov 2026 --> Nov 2030
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    6ms
    GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T Cells Against Cancers (clinicaltrials.gov)
    P1, N=30, Recruiting, Second Affiliated Hospital of Guangzhou Medical University | Trial completion date: Aug 2026 --> Aug 2036 | Trial primary completion date: Aug 2024 --> Aug 2026
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18) • AXL (AXL Receptor Tyrosine Kinase) • MSLN (Mesothelin) • CD276 (CD276 Molecule) • GPC3 (Glypican 3) • TGFB1 (Transforming Growth Factor Beta 1) • GUCY2C (Guanylate Cyclase 2C) • PSCA (Prostate Stem Cell Antigen 2)
    |
    GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T cells
    6ms
    Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma (clinicaltrials.gov)
    P1, N=30, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Checkpoint inhibition
    |
    MSLN (Mesothelin)
    |
    cyclophosphamide • ATA2271
    8ms
    AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, Arsenal Biosciences, Inc. | Trial primary completion date: Mar 2024 --> Dec 2024
    Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    cyclophosphamide • AB-1015
    8ms
    EVEREST-2: A seamless phase 1/2 study of A2B694, a mesothelin (MSLN) logic-gated Tmod CAR T-cell therapy, in patients with solid tumors that show MSLN expression and human leukocyte antigen (HLA)-A*02 loss of heterozygosity (LOH). (ASCO 2024)
    Mol Immunol. 2020.
    CAR T-Cell Therapy • P1/2 data • Clinical • IO biomarker
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin)
    |
    Tempus HLA-LOH assay
    |
    Ovarian cancer CAR-T therapy
    8ms
    Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, Verismo Therapeutics
    New trial
    |
    SynKIR-110
    8ms
    Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin (clinicaltrials.gov)
    P1/2, N=113, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • MSLN (Mesothelin)
    |
    MSLN expression
    |
    Keytruda (pembrolizumab) • cyclophosphamide • iCasp9M28z T cell infusion
    10ms
    Phase 1 Study of UCMYM802 Injection in Mesothelin-positive Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=24, Recruiting, UTC Therapeutics Inc.
    New P1 trial
    11ms
    An Exploratory Study on the Treatment of Advanced Solid Tumors by Fast CAR T Cells (clinicaltrials.gov)
    P1, N=12, Recruiting, Shanghai Cell Therapy Group Co.,Ltd
    New P1 trial
    |
    cyclophosphamide
    11ms
    EVEREST-2: A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression (clinicaltrials.gov)
    P1/2, N=230, Recruiting, A2 Biotherapeutics Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin)
    |
    MSLN expression • HLA-A*02
    12ms
    EVEREST-2: A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression (clinicaltrials.gov)
    P1/2, N=230, Not yet recruiting, A2 Biotherapeutics Inc.
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin)
    |
    MSLN expression • HLA-A*02
    12ms
    A Study of TAK-103 in Adult With Solid Tumors (clinicaltrials.gov)
    P1, N=2, Active, not recruiting, Takeda | Recruiting --> Active, not recruiting | N=21 --> 2
    Enrollment closed • Enrollment change • Metastases
    |
    MSLN (Mesothelin)
    |
    MSLN expression
    |
    NIB103
    1year
    Development of a Regulated, Optimized Mesothelin Chimeric Antigen Receptor (CAR) for the Treatment of Mesothelin Positive Cancers (ASH 2023)
    Contrary to the conclusions of prior studies with MSLN-targeted CARs, membrane distal epitopes were superior to membrane proximal epitopes when binders were paired with the correct spacer, and shed MSLN and MUC16 were not inhibitory for the best-performing CARs, regardless of target epitope. Furthermore, regulated expression enhanced the potency and durability of response compared to constitutive expression. This approach may improve CAR activity in patients with MSLN+ solid tumors or leukemia.
    PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma) • MSLN (Mesothelin) • MUC16 (Mucin 16, Cell Surface Associated) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • IL2 (Interleukin 2) • ICAM1 (Intercellular adhesion molecule 1) • CARS1 (Cysteinyl-TRNA Synthetase 1) • CD58 (CD58 Molecule) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
    |
    MSLN positive • PD-1 elevation
    1year
    CAR T Cells in Mesothelin Expressing Cancers (clinicaltrials.gov)
    P1, N=65, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting | N=27 --> 65
    Enrollment closed • Enrollment change • CAR T-Cell Therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    cyclophosphamide • TmMSTN-01
    1year
    Tumor-targeted non-ablative radiation promotes solid tumor CAR T-cell therapy efficacy. (PubMed, Cancer Immunol Res)
    We use a nonablative dose of tumor-targeted radiation prior to systemic administration of mesothelin-targeted CAR T cells to assess infiltration, proliferation, antitumor efficacy, and functional persistence of CAR T cells at primary and distant sites of tumor...Our results strongly suggest that the use of tumor-targeted radiation prior to systemic administration of CAR T cells may substantially improve CAR T-cell therapy efficacy for solid tumors. Building on our observations, we describe a translational strategy of "sandwich" cell therapy for solid tumors that combines sequential metastatic site-targeted radiation and CAR T cells-a regional solution to overcome barriers to systemic delivery of CAR T cells.
    Journal • CAR T-Cell Therapy • IO biomarker
    |
    MSLN (Mesothelin)
    |
    MSLN expression
    |
    ATA2271
    1year
    BASECAMP-1: A master prescreening study to identify patients with high-risk or metastatic solid tumors with HLA loss of heterozygosity (LOH) in preparation for Tmod CAR T-cell therapy trials (SITC 2023)
    BASECAMP-1 is an ongoing prescreening study to: 1) Identify patients with tumor-associated HLA LOH and eligible for Tmod CAR T-cell therapy, and 2) Obtain leukapheresis in preparation for the autologous CAR T-cell therapy trials EVEREST-1 (A2B530 targeting carcinoembryonic antigen; NCT05736731) and EVEREST-2 (A2B694 targeting mesothelin). We have identified 52 patients across sites with study-specific disease types with HLA-A*02:01 LOH; of these, 13 are currently being screened, 23 have been found ineligible, and 16 have consented. This demonstrated the feasibility of leveraging a diagnostic during routine clinical workup to identify rare, molecularly defined patients for personalized clinical studies.
    CAR T-Cell Therapy • Clinical • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    HLA-A*02
    |
    Tempus HLA-LOH assay
    |
    A2B530
    1year
    Preclinical potency assessment of SynKIR-110, a mesothelin-specific KIR-CAR T cell therapy for mesothelioma (SITC 2023)
    These data support further clinical development of SynKIR-110 in patients with advanced solid tumors. SynKIR-110 is currently being investigated in a Phase I clinical trial STAR-101 (NCT05568680).
    Preclinical • CAR T-Cell Therapy
    |
    MSLN (Mesothelin)
    |
    MSLN positive
    |
    SynKIR-110
    1year
    EVEREST-2: A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression (clinicaltrials.gov)
    P1/2, N=230, Not yet recruiting, A2 Biotherapeutics Inc.
    New P1/2 trial • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • MSLN (Mesothelin)
    |
    MSLN expression • HLA-A*02
    over1year
    Study of αPD1-MSLN-CAR T Cells to Evaluate the Safety, Tolerability, and Effectiveness for Patients With MSLN-positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=30, Recruiting, Shanghai Cell Therapy Group Co.,Ltd | Not yet recruiting --> Recruiting | Trial completion date: Oct 2023 --> Jan 2025 | Trial primary completion date: Dec 2022 --> Jul 2024
    Enrollment open • Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • MSLN (Mesothelin)
    |
    PD-L1 expression
    |
    BZD1901
    over1year
    Study of LD013 in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer (clinicaltrials.gov)
    P=N/A, N=3, Completed, Weijia Fang, MD | Recruiting --> Completed | Trial completion date: Feb 2026 --> Feb 2023 | Trial primary completion date: Feb 2026 --> Feb 2023
    Trial completion • Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    MSLN (Mesothelin)
    |
    LD013
    over1year
    Phase I/II Study of αPD1-MSLN-CAR T Cells in MSLN-positive Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=42, Not yet recruiting, Shanghai Cell Therapy Group Co.,Ltd
    New P1/2 trial • CAR T-Cell Therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • MSLN (Mesothelin)
    |
    PD-L1 expression
    |
    BZD1901
    over1year
    A Study of TAK-103 in Adult With Solid Tumors (clinicaltrials.gov)
    P1, N=21, Recruiting, Takeda | Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Oct 2026 --> Oct 2027
    Trial completion date • Trial primary completion date • Metastases
    |
    MSLN (Mesothelin)
    |
    MSLN expression
    |
    NIB103
    over1year
    UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=87, Recruiting, Zhejiang University
    New P1 trial
    |
    IL6 (Interleukin 6) • MSLN (Mesothelin) • IL10 (Interleukin 10)
    |
    cyclophosphamide • UCLM802
    almost2years
    MSLN-targeted CAR-T Cells in Solid Tumors. (clinicaltrials.gov)
    P1, N=87, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P1 trial • CAR T-Cell Therapy • Metastases
    |
    IL6 (Interleukin 6) • MSLN (Mesothelin) • IL10 (Interleukin 10)
    |
    UCLM802
    almost2years
    Mesothelin-CAR-T Cells Against Cancers (clinicaltrials.gov)
    P1, N=30, Recruiting, Second Affiliated Hospital of Guangzhou Medical University
    New P1 trial • CAR T-Cell Therapy • IO biomarker
    |
    MSLN (Mesothelin)
    |
    MSLN expression • MSLN positive
    |
    Mesothelin/GPC3/GUCY2C-CAR-T
    almost2years
    UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=87, Not yet recruiting, Peking University
    New P1 trial • CAR T-Cell Therapy • Metastases
    |
    IL6 (Interleukin 6) • MSLN (Mesothelin) • IL10 (Interleukin 10)
    |
    cyclophosphamide • UCLM802
    almost2years
    Non-viral mesothelin-targeted CAR-T cells armored with IFNg-induced secretion of PD-1 nanobody in treatment of malignant mesothelioma in phase I clinical trial (AACR 2023)
    After apheresis and lymphodepletion with cyclophosphamide and fludarabine... PD-1 nanobody secreted and MSLN targeting CAR-T cells have demonstrated promising efficacy on MPM patients. Besides CAR-T direct tumor killing activity, secreted PD-1 nanobodies may provide additional clinical benefit by invigorating CAR-T from PD-L1 inhibition, activating TILs and relieving local immunosuppression.
    Clinical • P1 data • CAR T-Cell Therapy • PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • MSLN (Mesothelin)
    |
    PD-L1 expression • MSLN expression
    |
    cyclophosphamide • fludarabine IV • BZD1901
    almost2years
    Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=0, Withdrawn, Shanghai Pudong Hospital | N=20 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • CAR T-Cell Therapy • Metastases
    |
    MSLN (Mesothelin)
    |
    cyclophosphamide • fludarabine IV • UCLM802
    almost2years
    CD40 Ligand Expressing MSLN-CAR T Cell Therapy in MSLN Positive Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Chinese PLA General Hospital
    New P1/2 trial • CAR T-Cell Therapy • Metastases
    |
    MSLN (Mesothelin) • CD40LG (CD40 ligand)
    |
    MSLN expression
    |
    albumin-bound paclitaxel • cyclophosphamide • fludarabine IV • CD40 ligand expressing MSLN-CAR T
    2years
    Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma (clinicaltrials.gov)
    P1, N=30, Recruiting, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Recruiting | Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
    Enrollment open • Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Checkpoint inhibition
    |
    MSLN (Mesothelin)
    |
    MSLN expression
    |
    cyclophosphamide • ATA2271
    2years
    αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=21, Recruiting, Shanghai Mengchao Cancer Hospital | Trial completion date: Sep 2022 --> Aug 2023 | Trial primary completion date: Jun 2022 --> Feb 2023
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • IL6 (Interleukin 6) • MSLN (Mesothelin) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    PD-L1 expression
    |
    BZD1901
    over2years
    Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=20, Recruiting, Shanghai Pudong Hospital
    New P1 trial • CAR T-Cell Therapy
    |
    MSLN (Mesothelin)
    |
    cyclophosphamide • fludarabine IV • UCLM802
    over2years
    A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer (clinicaltrials.gov)
    P1, N=15, Terminated, Shanghai East Hospital | N=34 --> 15 | Trial completion date: Nov 2024 --> Jun 2022 | Recruiting --> Terminated | Trial primary completion date: Nov 2022 --> Jun 2022; Both the sponsors and collaborator are considering terminating the study.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • CAR T-Cell Therapy
    |
    MSLN (Mesothelin)
    |
    cyclophosphamide • LCAR-M23