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NOT YET RECRUITING
NCT06742593
PHASE1

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

Sponsor: Suzhou Maximum Bio-tech Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-01-01

Completion Date

2026-12-30

Last Updated

2024-12-19

Healthy Volunteers

No

Interventions

DRUG

MT027 cells suspension

MT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China