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

Launched by SUZHOU MAXIMUM BIO-TECH CO., LTD. · Dec 17, 2024

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ClinConnect Summary

This clinical trial is studying a new treatment called MT027 for patients with certain types of brain and spinal cord tumors. MT027 is a special kind of therapy made from T cells (a type of white blood cell) taken from healthy donors, and it is designed to target a specific protein called B7-H3 found on cancer cells. This treatment is meant to be ready for use right away, which can help patients who need this type of therapy but have had trouble getting it due to long waiting times or complications with their own cells. The goal is to provide a safer and more affordable option for patients facing these serious cancers.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of a malignant tumor that has spread to the brain, spinal cord, or surrounding areas. They should also expect to live for at least three more months and have a good level of physical functioning. Participants will need to sign a consent form agreeing to take part in the study. It's important to note that certain individuals, such as those with specific health issues or pregnant women, will not be able to join the study to ensure their safety. If you or a loved one is interested in this trial, it could be a chance to access an innovative treatment option for challenging brain cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily participate in this study and provide a signed and dated written informed consent form prior to any study-specific procedures, sampling or analyses.
• • 2. Be aged 18 years or older, with no limitation on gender.
• • 3. 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.
• • 4. The expected survival period is at least 3 months.
• • 5. The Karnofsky Performance Scale (KPS) score is ≥ 70 points. -
• Exclusion Criteria:
• • 1. Known to be allergic to the investigational drug or its excipient components;
• • 2. Those with central nervous system metastases of hematological malignancies (such as lymphoma, leukemia, etc.);
• • 3. Those with metastases in the brainstem and high cervical spinal cord, including the midbrain, pons, medulla oblongata and C1/2 cervical spinal cord segments;
• • 4. 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;
• • 5. Pregnant or lactating women;
• • 6. 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.