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RECRUITING
NCT06726564
PHASE1

A Study of MT027 in Patients with Pleural Malignant Tumors

Sponsor: Suzhou Maximum Bio-tech Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

MT027 cells suspension

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

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China