MT027 / Suzhou Maximum Bio-tech - LARVOL DELTA

MT027 Cell Injection in Patients With Advanced Primary or Secondary Peritoneal Tumors (clinicaltrials.gov) - P=N/A | N=10 | Recruiting | Sponsor: Ruijin Hospital

New trial • Peritoneal Cancer

MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Zhejiang University

New P1 trial • Oncology • Peritoneal Cancer • Solid Tumor

A single-arm, dose-escalation Phase I clinical trial to evaluate the tolerability, safety, pharmacokinetic characteristics, and preliminary efficacy of MT027 cell injection in patients with brain, leptomeningeal, and spinal cord metastases from solid tumors (ChiCTR) - P=N/A | N=12 | Sponsor: Cancer Hospital, Chinese Academy of Medical Sciences; Cancer Hospital, Chinese Academy of Medical Sciences

New trial • Breast Cancer • Colorectal Cancer • Lung Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD276 • IL10 • IL2 • IL4 • IL6 • TNFA

Study of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Suzhou Maximum Bio-tech Co., Ltd.

Metastases • New P1 trial • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Study of MT027 in Patients with Recurrent or Progressive High-grade Glioma (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Suzhou Maximum Bio-tech Co., Ltd.

New P1 trial • Brain Cancer • CNS Tumor • Glioma • Malignant Glioma • Oncology • Solid Tumor

An exploratory investigator-initiated trial via intrathecal or intracerebroventricular delivery of B7H3-specific allogeneic universal CAR-T cells in patients with recurrent high-grade gliomas. (ASCOBT 2024) - "In patients with relapsed high-grade glioma, the intrathecal or ICV administration of MT027 cell therapy was found to be safe and well-tolerated. The toxicity of grade 3 or above was 1/5 of similar products. The pharmacokinetics and pharmacodynamics of single-dose and multiple-dose treatments were stable."

CAR T-Cell Therapy • Clinical • IO biomarker • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Graft versus Host Disease • Immunology • Oncology • Pain • Solid Tumor • CD276 • IFNG • IL6 • TNFA

T-MAXIMUM PHARMACEUTICAL Announces Latest Clinical Advances in Allogeneic CAR-T Cell Therapy Breakthrough for Solid Tumors (PRNewswire) - P=NA | N=12 | NCT05752877 | "MT027, the product of target B7H3 received US FDA orphan drug designation (ODD) on 2023 and will engage IND of US FDA in Q1 2025. As of March 2024, over 50 adult patients with recurrent high-grade glioma expressing B7H3 have undergone treatment with MT027. The preliminary safety and efficacy results demonstrate good therapeutic potential...The company presented an exploratory investigator-initiated trial involving the intrathecal or intracerebroventricular administration of B7H3-specific allogeneic CAR-T cells for the treatment of recurrent high-grade glioma. This study, focused on the use of B7H3-specific allogeneic universal CAR-T cells in patients with recurrent high-grade gliomas, was highlighted at the 2024 American Society of Clinical Oncology (ASCO) Breakthrough Summit."

Clinical data • IND • Glioma • Oncology • Solid Tumor

GenScript Biotech and T-MAXIMUM Biotech Form Strategic Alliance on cGMP sgRNA (PRNewswire) - "GenScript Biotech...and T-MAXIMUM Biotech...have formed a strategic collaboration agreement to enable the development of T-MAXIMUM's development CAR-T cell therapy using GenScript's CRISPR nucleic acid reagents...GenScript will provide T-MAXIMUM Biotech with various CRISPR reagents to support the development of its universal CAR-T products from discovery to commercialization. The partnership with GenScript will support T-MAXIMUM Biotech's strategic development plan to progress multiple products to the Phase II clinical research stage and deliver products to market within the next five years...In February of this year, based on comprehensive preclinical research and positive results from investigator-initiated clinical studies (IIT), T-MAXIMUM Biotech's MT027 obtained FDA ODD certification..."

Licensing / partnership • Orphan drug • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

WuXi Shengji and Maoxing Biologics Reach Strategic Cooperation on MT-027 Universal CAR-T Product [Google translation] (Daily Economic News - NBD) - "Every AI Express, according to Wu Ming Sheng Ji official micro news, June 6, 2023, Boston, Massachusetts, USA. WuXi Shengji and T-MAXIMUM Pharmaceutical Inc...jointly announced the conclusion of a strategic cooperation agreement. WuXi Shengji will provide Maoxing Biological’s MT-027 general-purpose CAR-T cell product in the United States with integrated testing, process development, application for batch production and IND application and other full-process services."

Licensing / partnership • Oncology • Solid Tumor

An exploratory clinical trial on intra-lumbar injection of B7H3-specific allogeneic universal CAR-T cells in patients with recurrent high-grade gliomas. (ASCO 2023) - "In patients with rHGGs, B7H3 UCAR-T cells was not associated with any toxic effects of grade 3 or higher. B7H3 UCAR-T cells resulted in a significantly longer overall survival and a higher objective response rate than history data. B7H3 UCAR-T cells persist well in patients."

CAR T-Cell Therapy • Clinical • IO biomarker • Brain Cancer • CNS Tumor • Diffuse Midline Glioma • Glioblastoma • Glioma • Graft versus Host Disease • Immunology • Oncology • Pain • Solid Tumor • CD276 • IL6

Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma (clinicaltrials.gov) - P=N/A | N=12 | Recruiting | Sponsor: Second Affiliated Hospital of Soochow University

CAR T-Cell Therapy • Metastases • New trial • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor • CD276 • PD-L1