Peritoneal TumorNCT07004647
MT027 Cell Injection in Patients With Advanced Primary or Secondary Peritoneal Tumors
A study testing Fludarabine in people with Peritoneal Tumor, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peritoneal Tumor
- What is being tested?
- Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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);
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- 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;
- 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 destruction/impaired production, requiring repeated transfusions or erythrocyte therapies, the patient's eligibility must be discussed with the sponsor based on clinical context prior to enrollment.
- 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 Infusion. Females of childbearing potential include: Premenopausal women .Women within 2 years postmenopausal.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jinlin Jiang contact
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Jun Zhang, 021-64741635, zj10977@rjh.com.cn
Jinlin Jiang, 13816423993
About this study
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
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.
Read the detailed 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.
- Conditions
- Peritoneal Tumor
- Being tested
- Fludarabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MT027 Cell injection (Targeting B7-H3 Generic generic chimeric antigen receptor T cell injection). | Experimental | Not described Receives: Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Incidence and severity of adverse events.
Measured: 2 years
Serious Adverse Events (SAEs)
Incidence and severity of serious adverse events.
Measured: 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.
Measured: 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.
Measured: 4 weeks after the CAR-T cells infusion
Secondary outcomes (9)
Objective Response Rate (ORR)
The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Measured: 2 years
Disease Control Rate (DCR)
Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Measured: 2 years
Duration of Overall Response (DOR)
Time from documentation of disease response to disease progression.
Measured: 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from CAR-T infusion to the date of the disease progression or death from any cause.
Measured: 2 years
Overall Survival (OS)
OS is defined as the time from CAR-T infusion to the date of death due to any cause.
Measured: 2 years
Bio-distribution of Anti mesothelin CAR-T cells
CAR copies will be measured by qPCR to evaluate the expansion and persistenc e of CAR-T cells in vivo. Cmax, Tmax, AUC0-tlast and AUC0-inf of CAR copies will be analyzed.
Cmax is the maximum CAR level in peripheral blood or bone marrow. Tmax is time to peak CAR level in blood or bone marrow. AUC0-tlast and AUC0-inf are area under the curve of the CAR level in blood .
Measured: 2 years
Cytokine Level in Peripheral Blood
Level of cytokines in serum.
Measured: 2 years
Anti-drug Antibodies
Number of participants with anti-drug antibodies.
Measured: 2 years
RP2D
The RP2D is the optimal dose level selected for further evaluation in Phase II clinical trials, based on safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy data gathered during Phase I dose-escalation studies. It represents the dose that balances maximum therapeutic benefit with acceptable toxicity for patients.
Measured: 4 weeks after the CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start15 Mar 2025
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal TumorStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Accelerated titration and 3+3 design dose escalation phase followed by dose expansion phase
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004647
- Sponsor's protocol ID
- MT027-PNT-003
- Status last verified
- Mar 2025
- First submitted
- 14 Apr 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07004647
- Acronym / sponsor ID
- MT027-PNT-003
- Conditions
- Peritoneal Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Accelerated titration and 3+3 design dose escalation phase followed by dose expansion phase
| Arm | Type | Receives |
|---|---|---|
| MT027 Cell injection (Targeting B7-H3 Generic generic chimeric antigen receptor T cell injection). | Experimental | Drug: Fludarabine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FludarabineD-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. | Drug | MT027 Cell injection (Targeting B7-H3 Generic generic chimeric antigen receptor T cell injection). |
Primary outcome
Adverse Events (AEs)
Time frame: 2 years
Incidence and severity of adverse events.
Serious Adverse Events (SAEs)
Time frame: 2 years
Incidence and severity of serious adverse events.
Adverse Events of Special Interest (AESI)
Time frame: 2 years
Adverse Events of Special Interest (AESI)(Incidence and severity ) Incidence and severity of adverse event of special interest.
Identification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs)
Time frame: 4 weeks after the CAR-T cells infusion
Incidence and severity of dose-limiting toxicities (DLTs) following infusion of CAR-T cell injection, at each dose level tested in dose escalation phase.
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of Overall Response (DOR)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Bio-distribution of Anti mesothelin CAR-T cells
Time frame: 2 years
Cytokine Level in Peripheral Blood
Time frame: 2 years
Anti-drug Antibodies
Time frame: 2 years
RP2D
Time frame: 4 weeks after the CAR-T cells infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinlin Jiang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fludarabine in people with Peritoneal Tumor, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhang (021-64741635, zj10977@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.