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A Study of MT027 in Patients with Pleural Malignant Tumors
Sponsor: Suzhou Maximum Bio-tech Co., Ltd.
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.
Official title: A Phase 1 Single Arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT027 in Patients with Pleural Malignant Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2024-05-15
Completion Date
2029-02
Last Updated
2024-12-10
Healthy Volunteers
No
Conditions
Interventions
MT027 cells suspension
MT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells
Locations (1)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China