B7-H3-positive Advanced Malignant Solid Tumors Advanced Primary Peritoneal Tumors or Secondary Abdominal Metastatic Malignant Solid TumorsPhase 1NCT06912152
MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors
A Phase 1 study testing MT027 CAR-T cells in people with B7-H3-positive Advanced Malignant Solid Tumors Advanced Primary Peritoneal Tumors or Secondary Abdominal Metastatic Malignant Solid Tumors, run by Zhejiang University at 1 site in China.
Trial summary
This is an open-label, single-arm phase I dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of MT027 in patients with advanced primary peritoneal malignancies or abdominal metastases secondary to malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B7-H3-positive Advanced Malignant Solid Tumors Advanced Primary Peritoneal Tumors or Secondary Abdominal Metastatic Malignant Solid Tumors
- What is being tested?
- MT027 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2025to 31 Dec 2028
- Phase
- Phase 1
- 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
- Patients must meet all of the following inclusion criteria to be enrolled in this study:
- Voluntarily participate in this study and provide a signed and dated written informed consent form before undergoing any study-specific procedures, sampling, or analyses;
- Aged 18-70 years (inclusive), regardless of gender;
- 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.
- Clear systemic treatment plan for primary and metastatic lesions, with no anticipated changes during the study;
- Confirmed peritoneal metastasis via biopsy, cytology, CT, or prior evidence;
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- Enhanced CT shows intraperitoneal space-occupying lesions with ≥1 measurable lesion (per iRECIST criteria); or evaluable malignant peritoneal effusion via ultrasound (per WHO criteria);
- 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;
- No intraperitoneal drug injections (including hyperthermic intraperitoneal chemotherapy) within 1 month before signing the informed consent, except diagnostic paracentesis;
- Expected survival ≥3 months;
- ECOG performance status (PS) score of 0-2;
- 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.
- Recovery of prior systemic treatment toxicity to ≤Grade 1 or baseline (except alopecia);
- Fertile males and females must agree to use contraception from informed consent until 180 days post-last MT027 cell infusion.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
Official title: 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 is an open-label, single-arm phase I dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of MT027 in patients with advanced primary peritoneal malignancies or abdominal metastases secondary to malignant solid tumors. The study primarily focuses on determining the maximum tolerated dose and recommended phase II dose through sequential cohort dose escalation, while secondarily characterizing the pharmacokinetic parameters and collecting initial efficacy data regarding tumor response.
This investigation comprehensively evaluates the pharmacodynamic and pharmacokinetic profile of MT027 cellular therapy through three primary objectives: (1) systematic monitoring of treatment-emergent adverse events and clinically significant laboratory parameter deviations; (2) assessment of antitumor activity with correlative biomarker analysis; and (3) characterization of cellular kinetics including biodistribution patterns, mechanistic pathways of therapeutic activity, and comprehensive immunogenicity assessment measuring both cellular/humoral immune responses against MT027 cells. The protocol further investigates potential host-versus-product immune reactions through longitudinal monitoring of donor-specific antibodies and cytokine release profiles, while employing advanced molecular tracking methodologies to elucidate cellular persistence and functional modulation within the tumor microenvironment.
Read the detailed description
This single-arm, dose-escalation phase I clinical trial aims to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of MT027 in patients with advanced primary peritoneal malignancies or secondary abdominopelvic metastatic solid tumors.
This phase I study implements a tripartite dose-escalation framework (1×10⁷, 3×10⁷, and 6×10⁷ cells/administration) with biweekly intravenous dosing. Post-initial dosing requires a 4-week observation period for dose-limiting toxicities (DLT) graded per NCI-CTCAE v5.0 criteria, followed by subsequent 14-day interval administrations. Following 6 completed treatment cycles (12 weeks), participants may either transition to surveillance follow-up or continue therapy per investigator-determined risk-benefit analysis.
The hybrid accelerated titration "3+3" design initiates with single-patient cohorts for preliminary dose evaluation, transitioning to conventional 3+3 methodology (minimum 3 patients/cohort) for subsequent dose levels. Protocol-defined dose escalation beyond predetermined thresholds requires documented consensus between investigators and sponsors, contingent upon comprehensive review of cumulative safety parameters (including DLT absence) and emerging efficacy indicators.
The trial progresses through sequential Phase IA (dose-finding) and Phase IB (dose-expansion) stages. Phase Ia cessation triggers include either confirmation of Recommended Phase II Dose (RP2D) or investigator-verified favorable therapeutic index at any dose level.
An interim analysis will be conducted upon Phase IA completion, followed by submission of an ethical amendment application prior to initiating Phase IB. Phase IB will be initiated with multi-cohort expansion (n=9-18 per cohort) across prespecified malignancies: colorectal adenocarcinoma (CRC), gastric carcinoma (GC), high-grade serous ovarian carcinoma (HGSOC), breast cancer (BC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), metastatic castration-resistant prostate cancer (mCRPC), clear cell renal cell carcinoma (ccRCC), and cervical squamous cell carcinoma (CSCC), etc.
- Being tested
- MT027 CAR-T cells
- Keywords
- MT027, B7-H3 CAR-T, Universal CAR-T, Solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT027 CAR-T cellsBiological
Prior to MT027 cell infusion, lymphodepleting chemotherapy with fludarabine and cyclophosphamide was administered.
Dose Group 1: 1×10⁷ cells per administration; Dose Group 1: 3×10⁷ cells per administration; Dose Group 1: 6×10⁷ cells per administration; Based on the data obtained, adjustments to the specific number of cells in the established dosage groups and/or the addition of dosage groups may be made after discussion between the collaborators and researchers. A dose reduction titration may also be conducted based on the completed dosage groups.
| Study group | Role | What they receive |
|---|---|---|
| MT027 CAR-T cells MT027 CAR-T cells are allogeneic genetically modified T cells. | Experimental | Not described Receives: Biological: MT027 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after MT027 cells infusion
Incidence and proportion of adverse events during the trial (NCI-CTCAE v5.0 criteria )
Measured: 28 days
Secondary outcomes (13)
Obtain the maximum tolerated dose of MT027 cells
Dose-limiting toxicity after cell infusion
Measured: 3 months
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
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
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
Overall Survival Rate （OSR）
Measured: 2 years
Progression-Free Survival Rate (PFSR)
Measured: 2 years
Puncture-Free Survival （PuFS）
Measured: 2 years
Objective Response Rate of peritoneal cavity effusion
Measured: 2 years
Symptoms and signs of peritoneal cavity effusion
Measured: 2 years
Bio-distribution of MT027 cells
The pharmacokinetic (PK) parameters will be calculated by measuring CAR copy numbers of MT027 cells in ascites and peripheral blood following single-dose and multiple-dose administrations, including:
Single-dose PK metrics: Area under the curve from 0 to 28 days (AUC<sub>0-28d</sub>), peak concentration (C<sub>max</sub>), time to peak concentration (T<sub>max</sub>), and elimination half-life (T<sub>1/2</sub>);
Steady-state PK parameters during and post-multiple dosing: Trough concentration at steady state (C<sub>min,ss</sub>), peak concentration at steady state (C<sub>max,ss</sub>), average steady-state concentration (C<sub>av,ss</sub>), fluctuation index (DF), area under the curve over a dosing interval at steady state (AUC<sub>0-τ</sub>), time to peak concentration at steady state (T<sub>max,ss</sub>), accumulation ratio (R<sub>ac</sub>), and persistence profile.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start12 May 2025 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B7-H3-positive Advanced Malignant Solid Tumors Advanced Primary Peritoneal Tumors or Secondary Abdominal Metastatic Malignant Solid TumorsStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Accelerated titration and 3+3 design dose escalation
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
- Investigators
- Weijia Fang, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912152
- Sponsor's protocol ID
- MT027-PNT-001
- Status last verified
- May 2025
- First submitted
- 28 Mar 2025
- Last updated
- 21 May 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06912152
- Acronym / sponsor ID
- MT027-PNT-001
- Keywords
- MT027, B7-H3 CAR-T, Universal CAR-T, Solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Apr 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 is an open-label, single-arm phase I dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of MT027 in patients with advanced primary peritoneal malignancies or abdominal metastases secondary to malignant solid tumors. The study primarily focuses on determining the maximum tolerated dose and recommended phase II dose through sequential cohort dose escalation, while secondarily characterizing the pharmacokinetic parameters and collecting initial efficacy data regarding tumor response.
This investigation comprehensively evaluates the pharmacodynamic and pharmacokinetic profile of MT027 cellular therapy through three primary objectives: (1) systematic monitoring of treatment-emergent adverse events and clinically significant laboratory parameter deviations; (2) assessment of antitumor activity with correlative biomarker analysis; and (3) characterization of cellular kinetics including biodistribution patterns, mechanistic pathways of therapeutic activity, and comprehensive immunogenicity assessment measuring both cellular/humoral immune responses against MT027 cells. The protocol further investigates potential host-versus-product immune reactions through longitudinal monitoring of donor-specific antibodies and cytokine release profiles, while employing advanced molecular tracking methodologies to elucidate cellular persistence and functional modulation within the tumor microenvironment.
Detailed description
This single-arm, dose-escalation phase I clinical trial aims to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of MT027 in patients with advanced primary peritoneal malignancies or secondary abdominopelvic metastatic solid tumors.
This phase I study implements a tripartite dose-escalation framework (1×10⁷, 3×10⁷, and 6×10⁷ cells/administration) with biweekly intravenous dosing. Post-initial dosing requires a 4-week observation period for dose-limiting toxicities (DLT) graded per NCI-CTCAE v5.0 criteria, followed by subsequent 14-day interval administrations. Following 6 completed treatment cycles (12 weeks), participants may either transition to surveillance follow-up or continue therapy per investigator-determined risk-benefit analysis.
The hybrid accelerated titration "3+3" design initiates with single-patient cohorts for preliminary dose evaluation, transitioning to conventional 3+3 methodology (minimum 3 patients/cohort) for subsequent dose levels. Protocol-defined dose escalation beyond predetermined thresholds requires documented consensus between investigators and sponsors, contingent upon comprehensive review of cumulative safety parameters (including DLT absence) and emerging efficacy indicators.
The trial progresses through sequential Phase IA (dose-finding) and Phase IB (dose-expansion) stages. Phase Ia cessation triggers include either confirmation of Recommended Phase II Dose (RP2D) or investigator-verified favorable therapeutic index at any dose level.
An interim analysis will be conducted upon Phase IA completion, followed by submission of an ethical amendment application prior to initiating Phase IB. Phase IB will be initiated with multi-cohort expansion (n=9-18 per cohort) across prespecified malignancies: colorectal adenocarcinoma (CRC), gastric carcinoma (GC), high-grade serous ovarian carcinoma (HGSOC), breast cancer (BC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), metastatic castration-resistant prostate cancer (mCRPC), clear cell renal cell carcinoma (ccRCC), and cervical squamous cell carcinoma (CSCC), etc.
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
| Arm | Type | Receives |
|---|---|---|
| MT027 CAR-T cells MT027 CAR-T cells are allogeneic genetically modified T cells. | Experimental | Biological: MT027 CAR-T cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients must meet all of the following inclusion criteria to be enrolled in this study:
- 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.
- Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases present).
- Serum creatinine ≤1.5×ULN; or CrCL ≥30 mL/min (Cockcroft-Gault formula).
- INR/PT ≤1.3×ULN; APTT ≤1.5×ULN.
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| MT027 CAR-T cellsPrior to MT027 cell infusion, lymphodepleting chemotherapy with fludarabine and cyclophosphamide was administered. Dose Group 1: 1×10⁷ cells per administration; Dose Group 1: 3×10⁷ cells per administration; Dose Group 1: 6×10⁷ cells per administration; Based on the data obtained, adjustments to the specific number of cells in the established dosage groups and/or the addition of dosage groups may be made after discussion between the collaborators and researchers. A dose reduction titration may also be conducted based on the completed dosage groups. | Biological | MT027 CAR-T cells MT027 CAR-T cells are allogeneic genetically modified T cells. |
Primary outcome
Incidence of Adverse events after MT027 cells infusion
Time frame: 28 days
Incidence and proportion of adverse events during the trial (NCI-CTCAE v5.0 criteria )
13 secondary outcomes
Obtain the maximum tolerated dose of MT027 cells
Time frame: 3 months
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
RP2D
Time frame: 4 weeks after the CAR-T cells infusion
Overall Survival (OS)
Time frame: 2 years
Overall Survival Rate （OSR）
Time frame: 2 years
Progression-Free Survival Rate (PFSR)
Time frame: 2 years
Puncture-Free Survival （PuFS）
Time frame: 2 years
Objective Response Rate of peritoneal cavity effusion
Time frame: 2 years
Symptoms and signs of peritoneal cavity effusion
Time frame: 2 years
Bio-distribution of MT027 cells
Time frame: 3 months
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 21 May 2025.
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.
Weijia Fang principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT027 CAR-T cells in people with B7-H3-positive Advanced Malignant Solid Tumors Advanced Primary Peritoneal Tumors or Secondary Abdominal Metastatic Malignant Solid Tumors, run by Zhejiang University 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 22 inclusion and 1 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 21 May 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Weijia Fang (+86-0571-87235147, weijiafang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events after MT027 cells infusion (time frame: 28 days). 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 21 May 2025.