MT027 treatment for advanced abdominal tumors
Phase I Dose-Escalation Study of MT027: Evaluating Tolerability, Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors
This study is testing a new CAR-T cell therapy called MT027 to see if it can safely help people with advanced abdominal tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06912152 on ClinicalTrials.gov |
What this trial studies
This open-label, single-arm phase I clinical trial evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of MT027 CAR-T cell therapy in patients with advanced primary peritoneal malignancies or secondary abdominal metastatic solid tumors. The study employs a dose-escalation approach to determine the maximum tolerated dose and recommended phase II dose, while also monitoring treatment-emergent adverse events and assessing antitumor activity. Participants will receive biweekly intravenous doses of MT027, with a structured observation period for dose-limiting toxicities and subsequent treatment cycles based on individual risk-benefit assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with advanced solid tumors that have failed multiple lines of prior therapy or for which no standard treatment options are available.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced abdominal tumors that have limited treatment alternatives.
How similar studies have performed: Other studies utilizing CAR-T cell therapies have shown promising results, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients must meet all of the following inclusion criteria to be enrolled in this study:
1. Voluntarily participate in this study and provide a signed and dated written informed consent form before undergoing any study-specific procedures, sampling, or analyses;
2. Aged 18-70 years (inclusive), regardless of gender;
3. Diagnosed with primary malignancy confirmed by pathology and/or histology (with complete pathological report provided), including:Advanced solid tumors that have failed ≥2 lines of prior standard therapy;Advanced solid tumors (e.g., gastric cancer, colorectal cancer, platinum-resistant advanced ovarian cancer, fallopian tube cancer, etc.) with no standard treatment available, or for which accessible treatments have failed, or for which the investigator deems the patient intolerant to accessible treatments based on comprehensive risk-benefit assessments (intolerance defined as ≥Grade 3 adverse reactions post-treatment, or reactions below Grade 3 but persistent or recurrent, impacting continued treatment). All related adverse reactions must resolve to ≤Grade 1 or return to baseline before screening or the first dose.Primary malignant peritoneal tumors confirmed by pathology and/or histology, including primary peritoneal cancer, peritoneal mesothelioma, etc., with failed or intolerable standard therapy;Other solid tumors with peritoneal metastasis judged by the investigator to lack standard treatment options.
4. Clear systemic treatment plan for primary and metastatic lesions, with no anticipated changes during the study;
5. Confirmed peritoneal metastasis via biopsy, cytology, CT, or prior evidence;
6. Enhanced CT shows intraperitoneal space-occupying lesions with ≥1 measurable lesion (per iRECIST criteria); or evaluable malignant peritoneal effusion via ultrasound (per WHO criteria);
7. Willingness to provide recent FFPE tissue samples, pathological slides (8 consecutive unstained slides), or ascites tumor cells for B7-H3 expression testing, with confirmed B7-H3 positivity;
8. No intraperitoneal drug injections (including hyperthermic intraperitoneal chemotherapy) within 1 month before signing the informed consent, except diagnostic paracentesis;
9. Expected survival ≥3 months;
10. ECOG performance status (PS) score of 0-2;
11. Laboratory results during screening meeting the following criteria:
Blood tests (within 14 days):
WBC ≥3.0×10\^9/L; ANC ≥1.5×10\^9/L; Lymphocytes ≥0.8×10\^9/L; Platelets ≥90×10\^9/L; Hemoglobin ≥90 g/L (transfusions or erythropoietin allowed). Patients requiring repeated transfusions due to active bleeding or chronic conditions must be discussed with the sponsor.
Liver function (within 7 days):
Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases present).
Renal function (within 7 days):
Serum creatinine ≤1.5×ULN; or CrCL ≥30 mL/min (Cockcroft-Gault formula).
Coagulation (within 7 days):
INR/PT ≤1.3×ULN; APTT ≤1.5×ULN.
12. Recovery of prior systemic treatment toxicity to ≤Grade 1 or baseline (except alopecia);
13. Fertile males and females must agree to use contraception from informed consent until 180 days post-last MT027 cell infusion.
Exclusion Criteria:
* 1\. Known allergy to the investigational drug or its excipients; 2. Contraindications to peritoneal puncture or deemed unlikely to benefit from intraperitoneal therapy; 3. MSI-H/dMMR colorectal cancer patients not previously treated with immunotherapy; 4. Extensive liver metastases (\>70% liver involvement); 5. Confirmed portal vein thrombosis; 6. Bowel obstruction within 4 weeks before dosing; 7. Conditions limiting drug diffusion (e.g., compartmentalized or gelatinous ascites); 8. Surgery or radiotherapy within 4 weeks before the first dose; 9. Systemic steroids (excluding replacement therapy) or immunosuppressants within 1 week before treatment; 10. Participation in other drug trials within 4 weeks before screening; 11. Prior B7-H3-targeted therapy (antibody/ADC/cell therapy) without confirmed B7-H3 positivity via biopsy; 12. Severe allergy to any component of the investigational drug or biologics; 13. Concurrent malignancies (except cured cervical carcinoma in situ or basal cell carcinoma); 14. Severe autoimmune diseases; 15. Prior allogeneic tissue/organ transplant; 16. Live vaccines within 2 weeks before cell therapy or planned during the study; 17. Active HBV, HCV (unless RNA-negative), HIV, syphilis, EBV, or CMV infection; 18. Active systemic infection or coagulation disorders; 19. Severe cardiac (NYHA Class III+), hepatic (Child-Pugh C+), renal (CKD ≥Stage 4), or pulmonary insufficiency; 20. Pregnancy or lactation; 21. Any condition deemed unsuitable by the investigator
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Weijia Fang — Zhejiang University
- Study coordinator: Weijia Fang
- Email: weijiafang@zju.edu.cn
- Phone: +86-0571-87235147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.