Safety and Efficacy of TCR-like CAR-TPhase 1/2NCT05963100
Clinical Study of TCR-like CAR-T Cell Targeted MSLN in the Treatment of Ovarian Cancer
A Phase 1/2 study testing TCR-like CAR-T in people with Safety and Efficacy of TCR-like CAR-T, run by Zhongda Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to test TCR-like CAR-T in the Treatment of MSLN positive Ovarian Cancer. The main question it aims to answer are: the safety and efficacy of TCR-like CAR-T in the Treatment of MSLN positive Ovarian Cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Safety and Efficacy of TCR-like CAR-T
- What is being tested?
- TCR-like CAR-T
- 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
- 7 Aug 2023to 16 May 2026
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of advanced platinum-resistant ovarian cancer, with a positive rate of IHC mesothelin in tumor tissue ≥ 26% [Participants need to undergo fresh tumor tissue biopsy for biomarker analysis]. If biopsy is not possible, it is necessary to provide archived tumor tissue (at least 8 unstained FFPE sections) within 18 months. If there have been multiple tumor tissue collections in the past, the newly collected samples will be prioritized
- Non resectable advanced ovarian cancer that has failed standard treatment (has previously received at least one platinum containing systemic chemotherapy regimen) or lacks effective treatment methods
- At least 1 measurable lesion (according to RECIST 1.1 standard)
- ECOG score 0-1 and estimated survival greater than 3 months
- The laboratory test results should at least meet the following indicators: Lambda Left ventricular Ejection fraction ≥ 45%; Creatinine clearance rate ≥ 50mL/min; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Absolute lymphocyte count (ALC) ≥ 0.7 × 109/L; Platelet count (PLT) ≥ 100 × 109/L; Hemoglobin ≥ 90g/L; Blood oxygen saturation>91%; Total bilirubin ≤ 2 × ULN (upper limit of normal value): alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Researchers have determined that ALT and AST abnormalities caused by diseases (such as liver metastasis or bile duct obstruction) or Gilbert syndrome can be relaxed to ≤ 5 × ULN;
- The researcher determines that the subject needs to recover from all toxicity related to the previous treatment to an acceptable baseline state, or the relevant toxicity needs to return to normal or level 1 of the NCI CTCAE 5.0 scoring standard; Excluding toxicity that the researcher determines will not increase the safety risk of subsequent study drug reinfusion, such as hair loss, vitiligo, etc;
- Can understand this experiment and have signed an informed consent form.
- Venous access with venous or single blood collection
Who cannot join
- Other malignant tumors other than ovarian cancer in the first five years of screening, in addition to fully treated cervical Carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and Ductal carcinoma in situ after radical surgery;
- Hepatitis B B surface antigen (HBsAg) or hepatitis B B core antibody (HBcAb) is positive, and the detection result of hepatitis B virus (HBV) DNA titer in peripheral blood is higher than 50IU/ml or the lower limit of the quantitative detection range of the research center; Hepatitis C virus (HCV) antibody is positive and the peripheral blood HCV RNA detection result is higher than the lower limit of the quantitative detection range of the research center; People who are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested positive for syphilis
- Patients with ovarian cancer metastasis to the central nervous system and/or other unstable Central nervous system disease (bleeding, active infarction, infection, etc.)
- Received attenuated live vaccine within 4 weeks before cell transfusion
- It is known that any ingredient used in the treatment of this study may cause allergic reactions
- Hypertension with poor drug control (systolic pressure>160mmHg and/or diastolic pressure>90mmHg) or cardio cerebral Vascular disease with clinical significance (such as activity), such as cerebrovascular accident (within 6 months before signing the master informed consent), myocardial infarction (within 6 months before signing the master informed consent), unstable angina pectoris, congestive heart failure classified as Grade II or above by New York Heart Association (NYHA), Severe arrhythmia cannot be controlled with medication or has potential impact on research and treatment; The electrocardiogram shows clinically significant abnormalities or an average QTcB of ≥ 450ms after 3 consecutive attempts (with an interval of at least 5 minutes)
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- Concomitant with other serious organic or mental illnesses
- Suffering from systemic active infections that require treatment
- Suffering from autoimmune diseases: the history of Autoimmune disease determined by the researcher to be unsuitable for this study, such as systemic lupus erythematosus, vasculitis, and invasive lung diseases, should be excluded (except for Vitiligo subjects)
- Systematically available pine steroids (local use allowed), Hydroxycarbamide and immunomodulators (such as: α or γ Interferon, GM-CSF, mTOR inhibitor, cyclosporin, Thymosin, etc.)
- Chemotherapy was received 2 weeks before screening, immunotherapy was received within 4 weeks, radiation therapy was received 12 weeks before screening, or other anti-tumor treatment drugs had a washout period of less than 5 half-lives
- Pregnant or lactating women, and female subjects who plan to conceive within 1 year after cell transfusion
- Subjects with any coexisting medical conditions or diseases that the researcher determines may affect the conduct of this experiment
- Patients who have received other cell gene therapy products within 6 months prior to cell reinfusion and are considered unsuitable for inclusion by researchers
- The researcher determines that the patient is unable to complete all visits or procedures required by the research protocol (including the follow-up period), or has insufficient compliance to participate in this study; Or patients deemed unsuitable for inclusion by researchers
- Items included in the selection and exclusion criteria for the pre screening period audit
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test TCR-like CAR-T in the Treatment of MSLN positive Ovarian Cancer. The main question it aims to answer are: the safety and efficacy of TCR-like CAR-T in the Treatment of MSLN positive Ovarian Cancer.
- Conditions
- Safety and Efficacy of TCR-like CAR-T
- Being tested
- TCR-like CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCR-like CAR-TBiological
intravenous drip of TCR-like CAR-T with indicated doses
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1*10^6/kg | Experimental | Not described Receives: Biological: TCR-like CAR-T |
| Experimental 1*10^7/kg | Experimental | Not described Receives: Biological: TCR-like CAR-T |
| Experimental 3*10^6/kg | Experimental | Not described Receives: Biological: TCR-like CAR-T |
| Experimental 2*10^7/kg | Experimental | Not described Receives: Biological: TCR-like CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of KT127 cells
The highest dose level (cells/kg) where ≤2/6 evaluable subjects experience protocol-defined dose-limiting toxicities (DLTs) within 14 days post-infusion, with dose escalation terminated based on pre-specified safety criteria.
Measured: up to second year
Adverse events (AEs)
The ASTCT 2019 standard will be used to grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and the CTCAE version 5.0 standard will be used to grade other adverse events. Unless otherwise specified in the protocol, all AEs that occur during the entire study period will be evaluated.
Measured: up to second year
Secondary outcomes (3)
objective response rate(ORR)
The objective response rate evaluation will be based on the researcher's evaluation of imaging, and the efficacy evaluation will refer to the evaluation criteria for solid tumors (RECIST 1.1) The objective response rate evaluation will be based on the researcher's evaluation of imaging, and the efficacy evaluation will refer to the evaluation criteria for solid tumors(RECIST 1.1)
Measured: up to second year
progression-free survival(PFS)
Progressive free survival is the time from receiving investigational drug treatment to the onset of the first PD or death from any cause in the absence of documented PD
Measured: up to second year
Overall survival(OS)
The total survival period is the time between receiving investigational drug treatment and subject death due to various reasons
Measured: up to second year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start7 Aug 2023
- Primary completion16 May 2026 (estimated)
- Study completion16 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Efficacy of TCR-like CAR-TStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- dose climbing test
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Shen, Zhongda Hospital
- Investigators
- Yang Shen, PhD, Study chair, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963100
- Sponsor's protocol ID
- 2023010142
- Status last verified
- Mar 2025
- First submitted
- 19 Jul 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of TCR-like CAR-T Cell Targeted MSLN in the Treatment of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05963100
- Acronym / sponsor ID
- 2023010142
- Conditions
- Safety and Efficacy of TCR-like CAR-T
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 16 May 2026 (estimated)
- Study completion
- 16 May 2026 (estimated)
- First posted
- 27 Jul 2023 (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.
The goal of this clinical trial is to test TCR-like CAR-T in the Treatment of MSLN positive Ovarian Cancer. The main question it aims to answer are: the safety and efficacy of TCR-like CAR-T in the Treatment of MSLN positive Ovarian Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- dose climbing test
| Arm | Type | Receives |
|---|---|---|
| Experimental 1*10^6/kg | Experimental | Biological: TCR-like CAR-T |
| Experimental 1*10^7/kg | Experimental | Biological: TCR-like CAR-T |
| Experimental 3*10^6/kg | Experimental | Biological: TCR-like CAR-T |
| Experimental 2*10^7/kg | Experimental | Biological: TCR-like CAR-T |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of advanced platinum-resistant ovarian cancer, with a positive rate of IHC mesothelin in tumor tissue ≥ 26% [Participants need to undergo fresh tumor tissue biopsy for biomarker analysis]. If biopsy is not possible, it is necessary to provide archived tumor tissue (at least 8 unstained FFPE sections) within 18 months. If there have been multiple tumor tissue collections in the past, the newly collected samples will be prioritized
- Non resectable advanced ovarian cancer that has failed standard treatment (has previously received at least one platinum containing systemic chemotherapy regimen) or lacks effective treatment methods
- At least 1 measurable lesion (according to RECIST 1.1 standard)
- ECOG score 0-1 and estimated survival greater than 3 months
- The laboratory test results should at least meet the following indicators: Lambda Left ventricular Ejection fraction ≥ 45%; Creatinine clearance rate ≥ 50mL/min; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Absolute lymphocyte count (ALC) ≥ 0.7 × 109/L; Platelet count (PLT) ≥ 100 × 109/L; Hemoglobin ≥ 90g/L; Blood oxygen saturation>91%; Total bilirubin ≤ 2 × ULN (upper limit of normal value): alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Researchers have determined that ALT and AST abnormalities caused by diseases (such as liver metastasis or bile duct obstruction) or Gilbert syndrome can be relaxed to ≤ 5 × ULN;
Key exclusion criteria (16 listed)
- Other malignant tumors other than ovarian cancer in the first five years of screening, in addition to fully treated cervical Carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and Ductal carcinoma in situ after radical surgery;
- Hepatitis B B surface antigen (HBsAg) or hepatitis B B core antibody (HBcAb) is positive, and the detection result of hepatitis B virus (HBV) DNA titer in peripheral blood is higher than 50IU/ml or the lower limit of the quantitative detection range of the research center; Hepatitis C virus (HCV) antibody is positive and the peripheral blood HCV RNA detection result is higher than the lower limit of the quantitative detection range of the research center; People who are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested positive for syphilis
- Patients with ovarian cancer metastasis to the central nervous system and/or other unstable Central nervous system disease (bleeding, active infarction, infection, etc.)
- Received attenuated live vaccine within 4 weeks before cell transfusion
- It is known that any ingredient used in the treatment of this study may cause allergic reactions
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 |
|---|---|---|
| TCR-like CAR-Tintravenous drip of TCR-like CAR-T with indicated doses | Biological | Experimental 1*10^6/kg, Experimental 1*10^7/kg, Experimental 2*10^7/kg, Experimental 3*10^6/kg |
Primary outcome
Maximum tolerated dose (MTD) of KT127 cells
Time frame: up to second year
The highest dose level (cells/kg) where ≤2/6 evaluable subjects experience protocol-defined dose-limiting toxicities (DLTs) within 14 days post-infusion, with dose escalation terminated based on pre-specified safety criteria.
Adverse events (AEs)
Time frame: up to second year
The ASTCT 2019 standard will be used to grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and the CTCAE version 5.0 standard will be used to grade other adverse events. Unless otherwise specified in the protocol, all AEs that occur during the entire study period will be evaluated.
3 secondary outcomes
objective response rate(ORR)
Time frame: up to second year
progression-free survival(PFS)
Time frame: up to second year
Overall survival(OS)
Time frame: up to second year
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 2 Apr 2025.
- 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. This study is not recruiting at the moment.
Yang Shen, PhD study chair
Zhongda 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 TCR-like CAR-T in people with Safety and Efficacy of TCR-like CAR-T, run by Zhongda 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 8 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 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 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?
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?
Maximum tolerated dose (MTD) of KT127 cells (time frame: up to second year). The study lists 2 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 2 Apr 2025.