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Table 1 Anti-mesothelin CAR T cell therapy clinical trials in malignant mesothelioma

From: Anti-Mesothelin CAR T cell therapy for malignant mesothelioma

clinicaltrials.gov Identifier Phase Intervention Additional therapy Cancer type Delivery Sponsor Study completion Construct information Status / Outcome
NCT01583686 I/II Anti-mesothelinCAR-transduced peripheral blood lymphocytes fludarabine, cyclophosphamide, IL-2 MSLN expressing tumors Systemic National Cancer Institute (NCI), USA Dec-18 SS1 scFv Terminated due to slow/insufficient accrual.
Positive results for safety but low efficacy.
Best OR: 1/15 with SD. 14/15 with PD.
NCT01355965 I mRNA anti-MSLN
CAR-T cells
  MPM, PDAC Systemic University of Pennsylvania, USA Oct-15 SS1 mouse scFv fused to the 4–1-BB and CD3ζ signaling domains Completed.
Positive results (Primary endpoint: safety). Best OR: 2/18 patient showed transient response (Ref. 32, 33).
NCT02159716 I Anti-MSLN CAR-T cells
(CART-meso)
  MPM, PDAC, ovarian Systemic University of Pennsylvania, USA Nov-15 SS1 mouse scFV fused to the 4-1BB and CD3ζ signaling domains Completed.
Positive results (Primary endpoint: safety). Low persistence and low tumor infiltration were observed.
Best OR: 6/15 patients with SD (Ref. 34).
NCT03054298 I Anti-MSLN CAR-T cells (huCART-meso) cyclophosphamide MSLN expressing tumors Systemic and intrapleural University of Pennsylvania, USA Mar-21 SS1 humanized scFV Recruiting.
NCT03608618 I mRNA anti-MSLN CAR PBMC (MCY-M11) cyclophosphamide Peritoneal Mesothelioma,Fallopian Tube and ovary Adenocarcinoma,Primary Peritoneal Carcinoma Intraperitoneal MaxCyte, Inc., USA May-22 NA Recruiting.
Preliminary results (ASCO 2020): positive results on safety. 4/11 patients with SD (Ref. 35).
NCT02414269 I/II Anti-MSLN CAR-T cells with suicide switch
(iCasp9M28z)
cyclophosphamide or pembrolizumab MPM Intrapleural Memorial Sloan Kettering Cancer Center, USA Apr-21 anti-MSLN scFv linked to the CD28 and CD3ζ signaling domains plus suicide gene inducible caspase 9 Recruiting.
Preliminary results (AACR 2019, ASCO 2019): positive results on safety, 2/19 patients with CR, 5/19 with PR, 4/19 with SD (Ref. 36, 37).
NCT04577326 I anti-MSLN CAR T cells with intrinsic anti-PD1 inhibition (M28z1XXPD1DNR) cyclophosphamide MPM Intrapleural Memorial Sloan Kettering Cancer Center, USA Sep-22 anti-MSLN scFv linked to the CD28 and CD3ζ signaling domains plus PD-1 DNR and 1XX ITAM modification Recruiting.
NCT03907852 I/II Anti-MSLN TRuC
(TC-210)
cyclophosphamide, pembrolizumab,
fludarabine
MSLN expressing tumors Systemic TCR2 Therapeutics, USA Jan-23 single-domain anti-MSLN antibody fused to the CD3-ε subunit Recruiting.
Preliminary results in 5 patients show positive results on safety and 2/5 patients with unconfirmed PR (Ref. 38).
NCT04489862 I Anti-MSLN CAR-T cells expressing PD-1 nanobodies   MPM, NSCLC Systemic Wuhan Union Hospital, China Dec-22 NA Recruiting.
NCT03638206 I/II Anti-MSLN CAR-T cells cyclophosphamide, fludarabine MPM Systemic Shenzhen BinDeBio Ltd., China Mar-23 NA Recruiting.
  1. Abbreviations: MSLN mesothelin, MPM malignant pleural mesothelioma, PDAC pancreatic ductal adenocarcinoma, OR overall response, SD stable disease, PD progressive disease, PR partial response, CR complete response, PBMC peripheral blood mononuclear cells, PD-1 Programmed cell death protein 1, KO knock out, NSCLC non-small cell lung cancer, DNR Dominant negative receptor