RecruitingPhase 1NCT06726564

A Study of MT027 in Patients with Pleural Malignant Tumors

A Phase 1 Single Arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT027 in Patients with Pleural Malignant Tumors

Sponsor

Suzhou Maximum Bio-tech Co., Ltd.

Enrollment

18 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

Malignant Pleural Effusion Advanced Malignant Solid Tumor Pleural Metastases Pleural Mesothelioma Pleura Carcinoma Pleural Malignant Mesothelioma

Summary

This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK/PD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy.. Subjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests MT027, a new drug injected directly into the pleural space (the space around the lungs), in patients with advanced solid tumors that have caused malignant pleural effusion — a buildup of cancer-related fluid around the lungs. **You may be eligible if...** - Age 18 or older - Have an advanced solid tumor (any type) confirmed by biopsy or pathology - Have malignant pleural effusion (fluid around your lungs caused by cancer) that requires drainage - Adequate organ function **You may NOT be eligible if...** - Have untreated cancer in the brain - Have active serious infections or uncontrolled autoimmune disease - Have had recent major surgery - Are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMT027 cells suspension

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

Locations(1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

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NCT06726564

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