NCT06726564

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

Recruiting now Phase 1 Last updated 5 December 2024

What this trial tests

Phase 1 trial testing MT027 cells suspension in Advanced Malignant Solid Tumor in 18 participants. Currently enrolling.

Timeline

15 May 2024

Primary endpoint
1 May 2026

1 February 2029

Quick facts

Lead sponsor	Suzhou Maximum Bio-tech Co., Ltd.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	15 May 2024
Primary completion	1 May 2026
Estimated completion	1 February 2029
Sites	1 location across China

Drugs / interventions tested

• MT027 cells suspension — full drug profile →

Conditions studied

• Advanced Malignant Solid Tumor — all drugs for Advanced Malignant Solid Tumor →
• Malignant Pleural Effusion — all drugs for Malignant Pleural Effusion →
• Pleura Carcinoma — all drugs for Pleura Carcinoma →
• Pleural Mesothelioma — all drugs for Pleural Mesothelioma →

Sponsor

Suzhou Maximum Bio-tech Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Advanced Malignant Solid Tumor or Malignant Pleural Effusion. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• adverse events (AE) and serious adverse events (SAE)
  Time frame: through study completion, an average of 1 year
• Dose Limiting Toxicity (DLT)
  Time frame: 28 days
• GvHD
  Time frame: through study completion, an average of 1 year
• CRS
  Time frame: through study completion, an average of 1 year
• Immune effector cell-associated neurotoxicity syndrome (ICANs)
  Time frame: through study completion, an average of 1 year

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advancing CRISPR genome editing into gene therapy clinical trials: progress and future prospects.
   Cetin B, Erendor F, Eksi YE, Sanlioglu AD, et al · · 2025 · cited 15× · PMID 40160040 · DOI 10.1017/erm.2025.10
2. B7-H3 in Cancer Immunotherapy-Prospects and Challenges: A Review of the Literature.
   Mielcarska S, Kot A, Dawidowicz M, Kula A, et al · · 2025 · cited 5× · PMID 40801642 · DOI 10.3390/cells14151209
3. Harnessing the potential of gene editing technology for CAR-T cell therapy of solid tumors.
   Khodabandehloo E, Rayati M, Ahmadi E, Naghdibadi M, et al · · 2025 · cited 2× · PMID 41276863 · DOI 10.1186/s41232-025-00398-x
4. The Tumor Environment in Peritoneal Carcinomatosis and Malignant Pleural Effusions: Implications for Therapy.
   Mirsky PO, Wagner PL, Mandic-Popov M, Donnenberg VS, et al · · 2025 · cited 1× · PMID 41097743 · DOI 10.3390/cancers17193217
5. From biology to therapy: current standards and emerging strategies in pleural mesothelioma.
   van Genugten JHLT, de Gooijer CJ, Baas P. · · 2026 · PMID 41971442 · DOI 10.3389/fonc.2026.1778121
6. Therapeutic applications of CRISPR-Cas9 gene editing.
   Bharti A, Mudge J. · · 2025 · PMID 41476860 · DOI 10.3389/fgeed.2025.1724291