Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue)Phase 1/2NCT07399769
Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors
A Phase 1/2 study testing CAR-T in people with Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue), run by Shenzhen University General Hospital at 1 site in China.
Trial summary
1. Study Title: Efficacy and safety of MSLN CAR-T in advanced malignant tumors 2. Study Objectives: Primary: To evaluate the safety and tolerability of MSLN-targeted CAR-T cell therapy in patients with stage III/IV advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue)
- What is being tested?
- CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Jan 2027
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years (≥18 and ≤75 years), either sex;
- The subject voluntarily participates in the study and provides written informed consent signed by the subject or his/her legally authorized representative;
- Histopathologically confirmed unresectable, locally advanced, recurrent, or metastatic solid malignant tumor; according to the AJCC TNM staging system (8th edition, 2017), subjects diagnosed with stage III or stage IV solid malignant tumors;
- Presence of measurable and evaluable lesions according to RECIST v1.1;
- Positive MSLN expression in tumor tissue confirmed by immunohistochemistry (IHC);
- The subject must have received standard first-line therapy and has experienced disease progression or is intolerant to such therapy;
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- The subject is not suitable for curative treatment modalities such as definitive chemoradiotherapy and/or surgery/immune checkpoint inhibitors, or refuses surgical resection;
- No antibody-based therapy administered within 2 weeks prior to cell therapy;
- ECOG performance status 0-2;
- No contraindications to peripheral blood leukapheresis;
- Estimated life expectancy ≥ 3 months.
Who cannot join
- History of allergy to any component of the cell product;
- Any of the following hematologic abnormalities on complete blood count (CBC): WBC ≤ 1 × 10^9/L, absolute neutrophil count (ANC) ≤ 0.5 × 10^9/L, absolute lymphocyte count (ALC) ≤ 0.5 × 10^9/L, or platelets (PLT) ≤ 25 × 10^9/L;
- Any of the following laboratory abnormalities, including but not limited to: serum total bilirubin ≥ 1.5 mg/dL; serum ALT or AST > 2.5 × ULN; serum creatinine ≥ 2.0 mg/dL;
- NYHA class III or IV heart failure per the New York Heart Association functional classification, or left ventricular ejection fraction (LVEF) < 50% on echocardiography;
- Abnormal pulmonary function with oxygen saturation (SpO₂) < 92% on room air;
- History of myocardial infarction, coronary angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;
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- Grade 3 hypertension with poor blood pressure control despite medical treatment;
- History of traumatic brain injury, disturbance of consciousness, epilepsy, or severe cerebral ischemic or hemorrhagic disease;
- Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;
- Presence of uncontrolled active infection;
- Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;
- Receipt of a live vaccine within 4 weeks prior to enrollment;
- Positive test results for HIV, HBV, HCV, and TPPA/RPR, and/or HBV carriers;
- History of alcohol abuse, illicit drug use, or psychiatric disorders;
- Participation in any other clinical study within 3 months prior to enrollment;
- Female subjects meeting any of the following:
- pregnant or breastfeeding; or
- planning pregnancy during the study period; or
- of childbearing potential and unable/unwilling to use effective contraception;
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
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
Shenzhen University General Hospital
Shenzhen, Other (Non U.s.), 518055
Guocheng Zhong, 17358524782, m18716354367@163.com
About this study
- Study Title: Efficacy and safety of MSLN CAR-T in advanced malignant tumors
- Study Objectives: Primary: To evaluate the safety and tolerability of MSLN-targeted CAR-T cell therapy in patients with stage III/IV advanced malignant tumors. Secondary: To preliminarily evaluate the efficacy of MSLN-targeted CAR-T cell therapy in this patient population. Exploratory: To assess in vivo expansion and persistence of infused MSLN-targeted CAR-T cells and explore correlations with clinical outcomes.
- Participant Intervention:
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and
-3 relative to the planned MSLN CAR-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
Read the detailed description
Detailed Description:
This is a prospective, interventional Phase I/II clinical study designed to evaluate the safety and efficacy of MSLN-targeted CAR-T cell therapy in patients with advanced malignant tumors. A total of 20 patients aged 18-75 years with unresectable, locally advanced, recurrent, or metastatic solid malignancies will be enrolled. All patients must have histopathologically confirmed disease and positive MSLN expression in tumor tissue.
MSLN CAR-T cells will be administered as a single intravenous infusion at a total dose of 0.5-2 × 10^6 CAR-T cells/kg. Eligible subjects (N=20) will be assigned by the investigator to receive MSLN CAR-T cell infusion.
Endpoints:
- Primary Endpoint:
- Incidence and severity of treatment-emergent adverse events (TEAEs) within 30 days after MSLN CAR-T cell infusion.
- Secondary Endpoints:
- Objective response rate (ORR = CR + PR) assessed within 8 weeks after infusion;
- Overall survival (OS) and progression-free survival (PFS) at 6 months;
- In vivo expansion and persistence kinetics of infused CAR-T cells.
- Being tested
- CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-TCombination product
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and
-3 relative to the planned MSLN CAR-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CART group | Experimental | Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and
-3 relative to the planned MSLN CAR-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy. Receives: Combination Product: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRAEs
Adverse events during treatment
Measured: From date of initial treatment to the 30 days after treatment
Secondary outcomes (1)
Disease-related clinical responses
Disease-related clinical responses include CR/PR/SD/PD
Measured: From date of enrollment until the date of clinical responses,up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Jan 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Yu, Principal investigator, Shenzhen University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399769
- Sponsor's protocol ID
- 112
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT07399769
- Acronym / sponsor ID
- 112
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen University General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 10 Feb 2026 (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.
- Study Title: Efficacy and safety of MSLN CAR-T in advanced malignant tumors
- Study Objectives: Primary: To evaluate the safety and tolerability of MSLN-targeted CAR-T cell therapy in patients with stage III/IV advanced malignant tumors. Secondary: To preliminarily evaluate the efficacy of MSLN-targeted CAR-T cell therapy in this patient population. Exploratory: To assess in vivo expansion and persistence of infused MSLN-targeted CAR-T cells and explore correlations with clinical outcomes.
- Participant Intervention:
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and
-3 relative to the planned MSLN CAR-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
Detailed description
Detailed Description:
This is a prospective, interventional Phase I/II clinical study designed to evaluate the safety and efficacy of MSLN-targeted CAR-T cell therapy in patients with advanced malignant tumors. A total of 20 patients aged 18-75 years with unresectable, locally advanced, recurrent, or metastatic solid malignancies will be enrolled. All patients must have histopathologically confirmed disease and positive MSLN expression in tumor tissue.
MSLN CAR-T cells will be administered as a single intravenous infusion at a total dose of 0.5-2 × 10^6 CAR-T cells/kg. Eligible subjects (N=20) will be assigned by the investigator to receive MSLN CAR-T cell infusion.
Endpoints:
- Primary Endpoint:
- Incidence and severity of treatment-emergent adverse events (TEAEs) within 30 days after MSLN CAR-T cell infusion.
- Secondary Endpoints:
- Objective response rate (ORR = CR + PR) assessed within 8 weeks after infusion;
- Overall survival (OS) and progression-free survival (PFS) at 6 months;
- In vivo expansion and persistence kinetics of infused CAR-T cells.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CART group | Experimental | Combination Product: CAR-TParticipants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned MSLN CAR-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18-75 years (≥18 and ≤75 years), either sex;
- The subject voluntarily participates in the study and provides written informed consent signed by the subject or his/her legally authorized representative;
- Histopathologically confirmed unresectable, locally advanced, recurrent, or metastatic solid malignant tumor; according to the AJCC TNM staging system (8th edition, 2017), subjects diagnosed with stage III or stage IV solid malignant tumors;
- Presence of measurable and evaluable lesions according to RECIST v1.1;
- Positive MSLN expression in tumor tissue confirmed by immunohistochemistry (IHC);
Key exclusion criteria (20 listed)
- History of allergy to any component of the cell product;
- Any of the following hematologic abnormalities on complete blood count (CBC): WBC ≤ 1 × 10^9/L, absolute neutrophil count (ANC) ≤ 0.5 × 10^9/L, absolute lymphocyte count (ALC) ≤ 0.5 × 10^9/L, or platelets (PLT) ≤ 25 × 10^9/L;
- Any of the following laboratory abnormalities, including but not limited to: serum total bilirubin ≥ 1.5 mg/dL; serum ALT or AST > 2.5 × ULN; serum creatinine ≥ 2.0 mg/dL;
- NYHA class III or IV heart failure per the New York Heart Association functional classification, or left ventricular ejection fraction (LVEF) < 50% on echocardiography;
- Abnormal pulmonary function with oxygen saturation (SpO₂) < 92% on room air;
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 |
|---|---|---|
| CAR-TParticipants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned MSLN CAR-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy. | Combination product | CART group |
Primary outcome
TRAEs
Time frame: From date of initial treatment to the 30 days after treatment
Adverse events during treatment
1 secondary outcome
Disease-related clinical responses
Time frame: From date of enrollment until the date of clinical responses,up to 2 years
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 10 Feb 2026.
- Individual participant dataSharing planned: No
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.
Li Yu principal investigator
Shenzhen University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CAR-T in people with Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue), run by Shenzhen University General 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 11 inclusion and 20 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 10 Feb 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Guocheng Zhong (0755-21839999, m18716354367@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRAEs (time frame: From date of initial treatment to the 30 days after treatment). 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 10 Feb 2026.