BZDS1901 / Shanghai Cell Therapy Group, AdAlta - LARVOL DELTA

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) - P1 | "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."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Solid Tumor • IFNG • IL6 • MSLN

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 | Sponsor: 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 • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSLN • PD-L1

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 | Sponsor: Shanghai Cell Therapy Group Co.,Ltd

CAR T-Cell Therapy • Metastases • New P1/2 trial • Oncology • Solid Tumor • MSLN • PD-L1

Shanghai Cell Therapy Group’s self-developed innovative CAR-T cell drug BZD1901 has been designated as an orphan drug in the United States [Google translation] (Shanghai Cell Therapy Group Press Release) - "On the evening of May 16, Beijing time, good news came from the United States. The self-developed autocrine PD1 nano-antibody armored cell drug BZD1901 project independently developed by Shanghai Cell Therapy Group successfully obtained FDA Orphan Drug Designation (ODD) for the treatment of mesothelioma."

Orphan drug • Lung Cancer • Mesothelioma • Oncology • Solid Tumor • Thoracic Cancer

"3) Building on observation 👆that PD1 May be resistance mech to CARTmeso. BZDS1901 adds PD1 nanobody. 11 MPM pts: 1 CR, 6 PR, 4 SD. Longest PFS 26 mo. @curemeso https://t.co/ymYVxS5aJ3" (@MMarmarelis)

Clinical • PD-1

China’s self-developed new CAR-T cell drug approved [Google translation] (Sina Corp) - "The reporter learned on the 25th that the autocrine nanobody CAR-T cell drug (BZD1901) independently developed by Shanghai Cell Therapy Group was approved by the Drug Evaluation Center of the State Food and Drug Administration for use in Treatment of mesothelin-positive advanced solid tumors."

Non-US regulatory • Oncology • Solid Tumor

αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Shanghai Mengchao Cancer Hospital | Trial completion date: Sep 2022 ➔ Aug 2023 | Trial primary completion date: Jun 2022 ➔ Feb 2023

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • IL10 • IL2 • IL6 • MSLN • PD-1 • PD-L1

Phase I clinical safety and efficacy observation of αPD-1-mesoCAR-T cells in the treatment of advanced gynecologic cancer. (ASCO 2022) - "The preliminary clinical study showed that the aPD-1-mesoCAR-T cells are safe for the treatment of gynecologic cancer and stabilized the diseases. More data of the treatment is warrantied to continually follow up these patients."

CAR T-Cell Therapy • Clinical • P1 data • Dermatology • Fatigue • Gynecologic Cancers • Oncology • Ovarian Cancer • Pruritus • IL2 • IL6 • MSLN

αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Shanghai Mengchao Cancer Hospital

CAR T-Cell Therapy • New P1 trial • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • IFNG • IL10 • IL2 • IL6 • MSLN • PD-1 • PD-L1 • TNFA

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; Not yet recruiting; Sponsor: Shanghai Cell Therapy Group Co.,Ltd

CAR T-Cell Therapy • Clinical • New P1 trial • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSLN • PD-L1