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New treatment option for Peritoneal Tumor
Official title MT027 Cell Injection in Patients With Advanced Primary or Secondary Peritoneal Tumors
ClinicalTrials.gov ID: NCT07004647
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peritoneal tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Voluntary participation in this study and provision of a signed and dated written informed consent form before any study-specific procedures...
- 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...
- Patients with secondary peritoneal tumors confirmed by cytological and/or histological diagnosis (e.g., secondary to adenocarcinomas of gastric...
- Contrast-enhanced CT/MRI demonstrating intra-abdominal space-occupying lesions with at least one evaluable target lesion (per iRECIST criteria);
You likely can't join 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;
See the full eligibility criteria
Who can join
- 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...
- 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)...
- 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
- people 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...
- 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;
- Laboratory tests during the screening period must meet the following criteria (no blood transfusion, G-CSF use, or medication to correct values within 14 days prior to hematological testing) :
- Blood routine (within 7 days) :
- White Blood Cells (WBC) ≥3.0×10⁹/L;
- Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L;
- Lymphocytes ≥0.8×10⁹/L;
- Platelets (PLT) ≥90×10⁹/L;
- Hemoglobin (HGB)≥90 g/L (\ transfusion and erythropoietin use are permitted\ ); If active bleeding or other ongoing conditions (e.g., hemolysis, bone marrow infiltration) lead to increased red blood cell...
- Liver function (within 7 days) :
- Total Bilirubin (TBIL) ≤1.5× upper limit of normal (ULN);
- ALT/AST≤2.5× ULN;
- Kidney function (within 7 days) :
- Serum Creatinine (Cr)≤1.5× ULN or Creatinine Clearance (CrCl) ≥30 mL/min (calculated by Cockcroft-Gault formula) Cockcroft-Gault formula);
- Coagulation function (within 7 days) :
- International Normalized Ratio (INR) or Prothrombin Time (PT)≤1.5× ULN;
- Activated Partial Thromboplastin Time (APTT) ≤1.5× ULN;
- Toxicities from prior systemic therapy must have recovered to≤ Grade 1 or baseline levels prior to the first dose (except for alopecia);
- Males of reproductive potential and females of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until 180 days after the last dose of MT027 Cell...
What rules you out
- 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;
- Active systemic infections, coagulopathy, or other significant comorbidities;
- Organ dysfunction: Cardiac: NYHA Class ≥III ；Hepatic: Child-Pugh C； Renal: CKD Stage ≥4 ；Pulmonary: Severe respiratory failure;
- Pregnancy/Lactation;
- Investigator-determined unsuitability based on clinical/laboratory findings.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.