Clinical Study of TCR-like CAR-T Cell Targeted MSLN in the Treatment of Ovarian Cancer

March 26, 2025 updated by: Yang Shen, Zhongda Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental 1*10^6/kg
Biological: TCR-like CAR-T
intravenous drip of TCR-like CAR-T with indicated doses
Experimental: Experimental 1*10^7/kg
Biological: TCR-like CAR-T
intravenous drip of TCR-like CAR-T with indicated doses
Experimental: Experimental 3*10^6/kg
Biological: TCR-like CAR-T
intravenous drip of TCR-like CAR-T with indicated doses
Experimental: Experimental 2*10^7/kg
Biological: TCR-like CAR-T
intravenous drip of TCR-like CAR-T with indicated doses

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to second year
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.
up to second year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
objective response rate(ORR)
Time Frame: up to second year
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)
up to second year
progression-free survival(PFS)
Time Frame: up to second year
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
up to second year
Overall survival(OS)
Time Frame: up to second year
The total survival period is the time between receiving investigational drug treatment and subject death due to various reasons
up to second year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongda Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yang Shen, PhD, Zhongda hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023010142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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