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

NCT06742593 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: MT027-BSM-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Adverse Events (AE) and Serious Adverse Events (SAE)

  through study completion, an average of 1 year

• Dose Limiting Toxicity (DLT)

  28 days

• Graft-versus-host Disease (GvHD)

  through study completion, an average of 1 year

• Cytokine Release Syndrome (CRS)

  through study completion, an average of 1 year

• Immune effector cell-associated neurotoxicity syndrome (ICANs)

  through study completion, an average of 1 year

Study Arms (1)

MT027

EXPERIMENTAL

Drug: MT027 cells suspension

Interventions

MT027 cells suspension DRUG

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

MT027

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this study and provide a signed and dated written informed consent form prior to any study-specific procedures, sampling or analyses.
• Be aged 18 years or older, with no limitation on gender.
• Have a definite diagnosis of malignant tumor confirmed by pathology and/or histology (and provide complete pathological report information), and have been verified by biopsy, cytology, imaging examinations, etc. or have had previous confirmation of brain, meninges, spinal cord metastases, including lung cancer, breast cancer, colorectal cancer, melanoma, renal cell carcinoma, etc. Other solid tumor CNS metastases without standard treatment as judged by the investigator can also be considered for enrollment.
• The expected survival period is at least 3 months.
• The Karnofsky Performance Scale (KPS) score is ≥ 70 points. -

You may not qualify if:

• Known to be allergic to the investigational drug or its excipient components;
• Those with central nervous system metastases of hematological malignancies (such as lymphoma, leukemia, etc.);
• Those with metastases in the brainstem and high cervical spinal cord, including the midbrain, pons, medulla oblongata and C1/2 cervical spinal cord segments;
• Those with severe insufficiency of heart, lung, liver and kidney functions; cardiac function: grade III or above according to the New York Heart Association (NYHA) criteria; liver function: grade C or above according to the Child-Pugh grading criteria; renal function: chronic kidney disease (CKD) stage 4 or above; renal insufficiency stage III or above; pulmonary function: severe respiratory failure symptoms involving other organs;
• Pregnant or lactating women;
• Those who are considered by the investigator to be unsuitable for participating in this clinical study due to any clinical or laboratory examination abnormalities or other reasons.

Sponsors & Collaborators

• Suzhou Maximum Bio-tech Co., Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Neurologic Manifestations; Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases

Study Officials

• Ning Li, MD/phD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuhang Wang, MD/phD

CONTACT

+86-01087788713; snowflake201@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 19, 2024
• Study Start: January 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)