MT027 Cell Injection in Patients With Advanced Primary or Secondary Peritoneal Tumors

NCT07004647 | Recruiting

• 1 other identifier: MT027-PNT-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, dose-escalation, investigator-initiated exploratory clinical trial designed to evaluate the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of MT027 Cell Injection in patients with advanced primary or secondary peritoneal tumors.

Conditions

Peritoneal Tumor

Outcome Measures

Primary Outcomes (4)

• Adverse Events (AEs)

  Incidence and severity of adverse events.

  2 years

• Serious Adverse Events (SAEs)

  Incidence and severity of serious adverse events.

  2 years

• Adverse Events of Special Interest (AESI)

  Adverse Events of Special Interest (AESI)(Incidence and severity ) Incidence and severity of adverse event of special interest.

  2 years

• Identification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs)

  Incidence and severity of dose-limiting toxicities (DLTs) following infusion of CAR-T cell injection, at each dose level tested in dose escalation phase.

  4 weeks after the CAR-T cells infusion

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  2 years

• Disease Control Rate (DCR)

  2 years

• Duration of Overall Response (DOR)

  2 years

• Progression-Free Survival (PFS)

  2 years

• Overall Survival (OS)

  2 years

Study Arms (1)

MT027 Cell injection (Targeting B7-H3 Generic generic chimeric antigen receptor T cell injection).

EXPERIMENTAL

Drug: Fludarabine

Interventions

Fludarabine DRUG

D-10 to D-2: Fludarabine (25 mg/m2/day) will be administered intravenously for 3 days;D-10 to D-2: Cyclophosphamide (250 mg/m2/day) will be administered intravenously for 3 days.

MT027 Cell injection (Targeting B7-H3 Generic generic chimeric antigen receptor T cell injection).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in this study and provision of a signed and dated written informed consent form before any study-specific procedures, sampling or analysis are conducted;
• Age range: 18 to 70 years old (inclusive), gender unrestricted
• Confirmed diagnosis of primary peritoneal tumors (including primary peritoneal carcinoma and malignant peritoneal mesothelioma) by cytological and/or histological methods, supported by complete pathological report documentation, with failure of first-line standard therapy.
• Patients with secondary peritoneal tumors confirmed by cytological and/or histological diagnosis (e.g., secondary to adenocarcinomas of gastric, colorectal, platinum-resistant advanced ovarian, or fallopian tube origin) who meet the following criteria: Treatment Failure: Progression after ≥2 prior lines of standard therapy; Lack of Standard Options: No available standard treatment, and/or Intolerance to Standard Therapy: Defined as: Grade ≥3 adverse events (AEs) related to prior therapy, or Persistent/recurrent AEs below grade 3 that preclude further treatment (as judged by the investigator).
• \*：Patients with pseudomyxoma peritonei (PMP) of ovarian or appendiceal origin will be excluded from this study.
• Contrast-enhanced CT/MRI demonstrating intra-abdominal space-occupying lesions with at least one evaluable target lesion (per iRECIST criteria);
• Prior to enrollment, systemic anti-tumor therapies must meet the following washout period requirements:
• Nitrosoureas and mitomycin C: ≥6 weeks;
• Other chemotherapeutic agents and small-molecule targeted agents: ≥3 weeks or • half-lives (including active metabolites), whichever is longer;
• Biological agents (such as immune checkpoint suppression), ≥4 weeks;
• Biologics (e.g., immune checkpoint inhibitors): ≥4 weeks
• Subjects must meet \*\*one\*\* of the following criteria: Willing to provide either: FFPE tissue blocks or 8 consecutive unstained slides from the most recent pathological specimen, or Ascites tumor cells (for cytological analysis), with B7-H3 positivity confirmed in the tumor tissue/ascites; OR Documented B7-H3 positivity in archival tumor tissue (e.g., from prior immunohistochemistry or RNA-seq reports).
• No intraperitoneal drug injections (including hyperthermic intraperitoneal chemotherapy, HIPEC) have been administered within 1 month prior to signing the informed consent form, except for diagnostic paracentesis.;
• Life expectancy ≥3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2;

You may not qualify if:

• Known hypersensitivity to the investigational product or its excipients;
• Other malignancies within 5 years (except cured carcinoma in situ of cervix/breast/prostate/thyroid/skin \[basal cell/squamous cell carcinoma\]);
• Contraindications to peritoneal puncture or investigator-determined unsuitability for intraperitoneal therapy;
• MSI-H (microsatellite instability-high)/dMMR (mismatch repair deficient) colorectal cancer patients without prior immunotherapy;
• Portal vein thrombosis confirmed by imaging;
• Bowel obstruction within 4 weeks prior to dosing;
• Peritoneal adhesions/jelly-like ascites (e.g., pseudomyxoma peritonei) limiting drug diffusion;
• Major surgery (except intraperitoneal port placement) or abdominal radiotherapy within 4 weeks before first dose;
• High-dose systemic corticosteroids (prednisone ≥20 mg/day) for \>14 days within 4 weeks prior to treatment (topical/inhaled steroids allowed);
• Participation in other clinical trials within 4 weeks prior to screening;
• Prior therapy targeting same pathway (antibody/ADC/cell therapy);
• Severe autoimmune diseases (e.g., lupus, rheumatoid arthritis);
• Recipients of allogeneic tissue/organ transplants;
• Live vaccination within 4 weeks before cell therapy or planned during study;
• Active infections: HBV (HBsAg+ with detectable DNA)、 HCV (Ab+ except RNA-undetectable) 、 HIV+ 、Syphilis (TPPA+) 、Active EBV/CMV infection;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

fludarabine

Central Study Contacts

Jun Zhang

CONTACT

021-64741635; zj10977@rjh.com.cn

Jinlin Jiang

CONTACT

13816423993

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Accelerated titration and 3+3 design dose escalation phase followed by dose expansion phase

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: June 4, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-03

Locations

CN (1)