NCT06742593

Study of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors

A Single-arm, Dose-escalating Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetic , and Efficacy of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Suzhou Maximum Bio-tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

MT027 is an off-the-shelf, allogeneic chimeric antigen receptor T cell (UCAR-T) injection prepared from healthy donor T cells targeting B7-H3. It is a next-generation, ready-to-use CAR-T product that can be used immediately and promptly for patients to solve the problem of unmet medical needs for a large number of patients who have a demand for CAR-T therapy but cannot receive it due to the common reasons of long production cycle, insufficient production capacity, and incompatibility of patients' T cells with the production conditions. In addition, the expected medical cost of allogeneic CAR-T cells is significantly lower, which can greatly alleviate the economic burden on patients. MT027 is prepared by expressing a chimeric antigen receptor (CAR) targeting B7H3 on gene-edited T cells through gene modification technology. MT027 products targeting the B7H3 target developed by Moxing Biotech avoid the potential graft-versus-host disease (GvHD) and host anti-graft reaction (HvGR) caused by the interaction between exogenous T cells and the patient's immune system, and have shown good safety and efficacy in recurrent high-grade glioma in the initial phase.

Detailed description

This study adopted a single-arm, open-label, single-center clinical trial design. The study population consisted of patients with high-grade glioma, aged 18 - 70 years old, whose B7H3 antigen expression was positive and had been confirmed by histology or cytology, and who had recurrence or progression after standard treatment. Subjects received local injection administration (intraventricular administration via an Ommaya reservoir or intrathecal administration into the lumbar cistern through lumbar puncture). For intrathecal injection via lumbar puncture, the dosage for each administration was divided into four dose levels: 1.0, 1.5, 2, 2.5 × 10⁷ cells per time, and the administration frequency was once every 4 weeks. During the study period, adverse events were observed and recorded, with special attention paid to product-specific adverse reactions such as graft-versus-host disease (GvHD), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). Cerebrospinal fluid (CSF) and blood samples were collected to analyze PK and PD indicators such as CAR copy numbers and cytokines in the samples. Efficacy evaluations were conducted once per cycle, and efficacy indicators such as overall survival (OS), 12-month overall survival rate (12m-OS), objective response rate (ORR), and disease control rate (DCR) were calculated.

Conditions

• Brain (Nervous System) Cancers
• Brain and Central Nervous System Tumors
• Brain Tumors

Interventions

Type	Name	Description
DRUG	MT027 cells suspension	MT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2024-12-19
• Last updated: 2024-12-19

Locations

1 site across 1 country: China