Clinical Trial

Disease: Advanced Primary or Secondary Peritoneal Tumors, (NCT07004647)

Disease info:

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancer), or malignant (cancer). Solid tumour types are named according to the type of cell they originate from. Examples of solid tumours are sarcomas, carcinomas, and lymphomas. Leukaemias (cancers of the blood) generally do not form solid tumours.

The word tumour does not always imply cancer. In discussing tumours that are malignant (cancerous), however, the term solid tumour is used to distinguish between a localised mass of tissue and leukaemia.

Frequency:
Excluding non-melanoma skin cancers, over 2 million new cancer cases are expected to be diagnosed in the US in 2025.
Official title:
An Investigator-Initiated, Single-Arm, Dose-Escalation Exploratory Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of MT027 Cell Injection in Patients With Advanced Primary or Secondary Peritoneal Tumors
Who:

Study Contact:

Name: Jun Zhang

Phone Number: 021-64741635

Email: zj10977@rjh.com.cn

Study Contact Backup:

Name: Jinlin Jiang

Phone Number: 13816423993

Sponsor:

Ruijin Hospital

Partners:
Locations:

China, Shanghai, Recruiting Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Contact: Jun Zhang 021-64741635 zj10977@rjh.com.cn Contact: Jinlin Jiang 13816423993

Study start:
Mar. 15, 2025
Enrollment:
10
Gene editing method:
CRISPR-Cas
Type of edit:
Gene insertion
Gene:
Gene expressing a CAR that targets B7-H3
Delivery method:
- Ex-vivo
Trial link:
https://clinicaltrials.gov/study/NCT07004647?term=nct07004647&rank=1
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This study evaluates the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of intrathecal or intracerebroventricular (ICV) injection of MT027 in glioma treatment. Partial clinical data have been presented at the 2024 ASCO Annual Meeting. Dose Groups: Three predefined dose levels: 1×10⁷ cells/dose、3×10⁷ cells/dose、6×10⁷ cells/dose. Administration frequency: Every 2 weeks (with a 4-week dose-limiting toxicity [DLT] observation period after the first injection, followed by subsequent injections every 2 weeks). Dose Escalation: Accelerated titration + 3+3 design: First dose cohort: Accelerated titration strategy. Subsequent cohorts: Standard "3+3" dose-escalation. Dose Adjustment: After reaching predefined dose levels, if no DLT or significant safety events occur, dose escalation decisions (including MTD determination) will be jointly reviewed by investigators and collaborators based on integrated safety and efficacy data. Primary Objectives: To assess the safety, tolerability, and determine the maximum tolerated dose (MTD) of MT027 cell injection in patients with advanced primary or secondary peritoneal tumors.

Last updated: Jun. 26, 2025
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