A Study of MT027 in Patients with Pleural Malignant Tumors
NCT06726564 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-12-10
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.
Conditions
- Advanced Malignant Solid Tumor
- Malignant Pleural Effusion
- Pleura Carcinoma
- Pleural Mesothelioma
- Pleural Malignant Mesothelioma
- Pleural Metastases
Interventions
- DRUG
-
MT027 cells suspension
MT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells
Sponsors & Collaborators
-
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
collaborator OTHER -
Suzhou Maximum Bio-tech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-15
- Primary Completion
- 2026-05-31
- Completion
- 2029-02-28
Countries
- China
Study Locations
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