Clinical trialPhase 1NCT05344976
MSLN STAR-T Cells in the Treatment of Advanced Malignant Solid Tumors
A Phase 1 study testing MSLN STAR-T cells, run by Peking University.
Trial summary
This is a single-center, single-arm, open-label Phase I study to evaluate the safety and efficacy of MSLN STAR-T cell immunotherapy in the treatment of advanced malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- MSLN STAR-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
- No sites listed yet
- Study dates
- 14 Apr 2022to 1 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years old, ≤ 70 years old, gender is not limited;
- Advanced malignant solid tumors confirmed by histology or cytology, including malignant mesothelioma (pleura, peritoneum, etc.), pancreatic cancer, ovarian cancer, intrahepatic bile duct cancer, lung cancer, gastric cancer, colorectal cancer, etc.;
- Patients with advanced malignant solid tumors who have relapsed after systemic therapy, or who cannot tolerate existing therapy, including but not limited to:
- Patients with malignant mesothelioma who have failed at least first-line therapy;
- Patients with pancreatic cancer who have failed at least first-line therapy;
- Patients with gastric cancer who have failed at least second-line therapy in the past;
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- Patients with ovarian cancer who have previously failed at least second-line platinum-sensitive or platinum-resistant therapy;
- Patients with intrahepatic cholangiocarcinoma who have failed at least first-line therapy;
- Patients with advanced non-small cell lung cancer (non-squamous cell carcinoma): positive for EGFR, ALK, ROS1, MET and other driver genes, disease progression or intolerance after targeted therapy; negative for EGFR, ALK, ROS1, MET and other driver genes If the subject has disease progression or intolerance after receiving ≥ 1 line of therapy in the past;
- Patients with colorectal cancer who have failed at least second-line therapy.
- Tumor tissue samples are positive for mesothelin (MSLN) (IHC test, positive rate > 10%);
- There are measurable target lesions on imaging (according to RECIST1.1) at the time of screening, the long diameter of non-lymph node lesions is ≥1.0cm, or the short diameter of lymph node lesions is ≥1.5cm;
- ECOG score 0-1 points;
- Expected survival period ≥ 3 months;
- Have the conditions to establish a peripheral blood mononuclear cell collection pathway, and have enough cells for STAR-T cell preparation;
- Has good bone marrow and organ function:
- Blood routine: absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (Hb) ≥85g/L; platelet count ≥75×109/L;
- Blood biochemistry: total bilirubin (TBIL) ≤ 2.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN) (for liver metastases) Patients may be ≤5 times ULN);
- Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal (ULN);
- Coagulation function: International Normalized Ratio (INR), Activated Partial Thrombin Time (APTT) ≤1.5×ULN, patients with liver metastases should be ≤2×ULN;
- Pulmonary function: with the lowest level of lung reserve, defined as CTCAE v5.0 ≤ grade 1 dyspnea and end-finger oxygen saturation ≥ 91% in the non-oxygen state.
Who cannot join
- Those with uncontrolled active infection at the time of screening; those who meet one of the following:
- Hepatitis B surface antigen (HBsAg) positive and/or hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copy number greater than the detection limit, hepatitis C antibody (HCV-Ab) positive and HCV-RNA copy number greater than the lower limit of detection, human immunodeficiency virus (HIV) antibody positive, Treponema pallidum (TP-Ab) antibody positive;
- Patients with or with a history of central nervous system diseases, such as history of epilepsy, stroke, severe brain damage, aphasia, paralysis, etc.;
- Patients with active brain metastases but who do not need any radiation, surgery or steroid therapy to control metastatic symptoms 1 month before screening can be enrolled;
- Systemic lupus erythematosus, combined with active or uncontrolled autoimmune diseases (such as Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.);
- Are receiving therapeutic dose or systemic glucocorticoid therapy (prednisone ≥ 20 mg/day or equivalent dose of other corticosteroids);
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- Toxicity or complications caused by previous interventions or treatments have not recovered to CTCAE v5.0 ≤ grade 2 or below (except for hair loss and abnormal values of laboratory tests judged by the investigator);
- Previously received other genetically modified T cell products (such as MSLN CAR-T or TCR-T cells), or treatment targeting MSLN;
- Patients who have received any of the following drugs or treatments within the specified time period prior to apheresis:
- Received any chemotherapy within 2 weeks or 5 half-lives, whichever is shorter, prior to apheresis;
- Received any macromolecule or small molecule targeted therapy such as monoclonal antibody, antibody-drug conjugate (ADC), double antibody, etc. within 4 weeks or 5 half-lives (whichever is shorter) before apheresis;
- Received radiotherapy within 6 weeks before apheresis. If the disease progresses in the radiotherapy site, or there are CT and other image-positive lesions in other non-radiotherapy sites, the group is allowed to enter the group; if there are CT and other image-positive lesions in other non-radiotherapy sites, it is allowed to 2 weeks before harvest, radiotherapy is performed on a single lesion;
- The presence of uncontrolled pleural effusion, pericardial effusion or ascites (ascites is defined as: ascites with positive signs of ascites on physical examination or ascites that needs to be controlled by intervention (only those with ascites shown by imaging without intervention can be included).
About this study
Official title: An Exploratory Clinical Study on the Safety and Efficacy of MSLN STAR-T Cells in Advanced Malignant Solid Tumors
This is a single-center, single-arm, open-label Phase I study to evaluate the safety and efficacy of MSLN STAR-T cell immunotherapy in the treatment of advanced malignant solid tumors.
Read the detailed description
This study is a single-center, dose-escalation, prospective, exploratory study to evaluate the safety and efficacy of MSLN STAR-T cells in patients with hepatocellular carcinoma. The study is divided into two phases: dose escalation and dose expansion. The total duration of each subject's participation in the study is expected to be 24 months, including the screening period, non-myeloablative chemotherapy pretreatment, cell infusion-observation period, and follow-up period.
- Being tested
- MSLN STAR-T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSLN STAR-T cellsBiological
Patients with advanced MSLN-positive solid tumors will be recruited, and autologous-derived MSLN-STAR-T cells will be infused intravenously at escalating doses of 1×10^7-1×10^8 MSLN-STAR-T cells. The CAR-T ratio will be monitored at predetermined times (day 0, day 4, day 7, day 10, day 14, day 28).
| Study group | Role | What they receive |
|---|---|---|
| MSLN STAR-T cells | Experimental | The patients will receive one dose of MSLN STAR-T.The dosage ranges from1×10^7 to 1×10^8 STAR-T+/kg. Receives: Biological: MSLN STAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adverse events
Percentage of participants with adverse events.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start14 Apr 2022 (estimated)
- Primary completion14 Oct 2024 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- More trials run by Peking 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
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344976
- Sponsor's protocol ID
- HXYT-I-018
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on the Safety and Efficacy of MSLN STAR-T Cells in Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05344976
- Acronym / sponsor ID
- HXYT-I-018
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 14 Apr 2022 (estimated)
- Primary completion
- 14 Oct 2024 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 25 Apr 2022 (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 a single-center, single-arm, open-label Phase I study to evaluate the safety and efficacy of MSLN STAR-T cell immunotherapy in the treatment of advanced malignant solid tumors.
Detailed description
This study is a single-center, dose-escalation, prospective, exploratory study to evaluate the safety and efficacy of MSLN STAR-T cells in patients with hepatocellular carcinoma. The study is divided into two phases: dose escalation and dose expansion. The total duration of each subject's participation in the study is expected to be 24 months, including the screening period, non-myeloablative chemotherapy pretreatment, cell infusion-observation period, and follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSLN STAR-T cells | Experimental | Biological: MSLN STAR-T cellsThe patients will receive one dose of MSLN STAR-T.The dosage ranges from1×10^7 to 1×10^8 STAR-T+/kg. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥ 18 years old, ≤ 70 years old, gender is not limited;
- Advanced malignant solid tumors confirmed by histology or cytology, including malignant mesothelioma (pleura, peritoneum, etc.), pancreatic cancer, ovarian cancer, intrahepatic bile duct cancer, lung cancer, gastric cancer, colorectal cancer, etc.;
- Patients with advanced malignant solid tumors who have relapsed after systemic therapy, or who cannot tolerate existing therapy, including but not limited to:
- Tumor tissue samples are positive for mesothelin (MSLN) (IHC test, positive rate > 10%);
- There are measurable target lesions on imaging (according to RECIST1.1) at the time of screening, the long diameter of non-lymph node lesions is ≥1.0cm, or the short diameter of lymph node lesions is ≥1.5cm;
Key exclusion criteria (13 listed)
- Those with uncontrolled active infection at the time of screening; those who meet one of the following:
- Hepatitis B surface antigen (HBsAg) positive and/or hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copy number greater than the detection limit, hepatitis C antibody (HCV-Ab) positive and HCV-RNA copy number greater than the lower limit of detection, human immunodeficiency virus (HIV) antibody positive, Treponema pallidum (TP-Ab) antibody positive;
- Patients with or with a history of central nervous system diseases, such as history of epilepsy, stroke, severe brain damage, aphasia, paralysis, etc.;
- Patients with active brain metastases but who do not need any radiation, surgery or steroid therapy to control metastatic symptoms 1 month before screening can be enrolled;
- Systemic lupus erythematosus, combined with active or uncontrolled autoimmune diseases (such as Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.);
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 |
|---|---|---|
| MSLN STAR-T cellsPatients with advanced MSLN-positive solid tumors will be recruited, and autologous-derived MSLN-STAR-T cells will be infused intravenously at escalating doses of 1×10^7-1×10^8 MSLN-STAR-T cells. The CAR-T ratio will be monitored at predetermined times (day 0, day 4, day 7, day 10, day 14, day 28). | Biological | MSLN STAR-T cells |
Primary outcome
Percentage of adverse events
Time frame: 3months
Percentage of participants with adverse events.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSLN STAR-T cells, run by Peking University.
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 21 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adverse events (time frame: 3months). 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 25 Apr 2022.