Suzhou Maximum Bio-tech Co. Ltd. is recruiting patients for a Phase 1 clinical trial testing MT027, a B7-H3 targeted CAR-T cell therapy, in people with pleural malignant tumors including pleural mesothelioma.
The trial, designated NCT06726564, aims to enroll up to 18 participants at a single site in Beijing, China.
About the Study
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.
Treatment Approach
This trial uses genetically engineered T cells that target B7-H3, a protein that is overexpressed on many solid tumors including pleural mesothelioma. Eligibility requires confirmed B7-H3 overexpression by immunohistochemistry. Unlike most mesothelioma CAR-T programs, which target mesothelin, MT027 is delivered locoregionally into the pleural space rather than infused intravenously.
Key trial details:
- Phase: Phase 1
- Sponsor: Suzhou Maximum Bio-tech Co. Ltd.
- Target antigen: B7-H3
- Enrollment target: 18
- Status: Recruiting
Why This Trial Matters
CAR-T cell therapy has revolutionized treatment for blood cancers, and researchers are working to adapt this approach for solid tumors like mesothelioma.
Study Locations
The trial is recruiting at Cancer Hospital, Chinese Academy of Medical Sciences, in Beijing, China.
How to Enroll
Patients interested in this trial should:
- Discuss eligibility with their oncologist
- Review the full eligibility criteria on ClinicalTrials.gov
- Contact the study coordinator for screening