Ovarian CancerEarly Phase 1NCT07420010

An Open-label, Single-arm Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of KT032 Cell Injection in Patients With Mesothelin-positive Advanced Solid Tumors.

A Early Phase 1 study testing KT032(anti-MSLN chimeric antigen receptor autologous T cell injection) in people with Ovarian Cancer and Mesothelioma, run by Weijia Fang, MD.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

An Open-label, Single-arm Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of KT032 Cell Injection in Patients With Mesothelin-positive Advanced Solid Tumors. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ovarian Cancer, Mesothelioma, Colon Cancer
What is being tested?: KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: 15 Mar 2026to 31 Dec 2028
Phase: Early 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18 to 75 years (inclusive), any gender;
Histopathologically confirmed diagnosis of advanced solid tumors (including but not limited to ovarian cancer, mesothelioma, colon cancer, etc.), with peritoneal or intraperitoneal metastasis as the primary disease manifestation;
Progression or intolerance to prior systemic standard-of-care treatment according to guidelines (systemic therapy includes but is not limited to systemic chemotherapy, molecular targeted therapy, etc.), and unsuitable for surgery or local treatment (including ablation therapy, interventional therapy, and radiotherapy); specifically: Ovarian cancer: Recurrence during or within 6 months after second-line or later platinum-based chemotherapy; Mesothelioma: Failure of, intolerance to, or ineligibility for at least first-line therapy; Colon cancer: Failure of, intolerance to, or ineligibility for at least third-line therapy;
Ovarian cancer: Progression, intolerance, or ineligibility after second-line standard therapy including carboplatin ± paclitaxel/albumin-bound paclitaxel/docetaxel/pegylated liposomal doxorubicin;
Advanced colon cancer: Progression, intolerance, or ineligibility after third-line standard therapy including cetuximab ± irinotecan/regorafenib/fruquintinib/trifluridine/tipiracil;
Mesothelioma: Progression, intolerance, or ineligibility after first-line standard therapy with pemetrexed combined with cisplatin/carboplatin;

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Presence of at least one measurable lesion per RECIST 1.1 criteria;
MSLN expression positivity in tumor tissue detected by immunohistochemistry (IHC), defined as IHC ≥2+ (i.e., ≥26% positive tumor cells stained); subjects must undergo fresh tumor tissue biopsy; if biopsy is not feasible, at least 5 archived tumor tissue slides collected within one year must be provided (if multiple tumor tissue collections exist, the most recent sample is preferred);
ECOG performance status 0-1 (see Appendix 1) and estimated life expectancy >12 weeks;
Adequate organ function with all following laboratory results prior to enrollment:
Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L (growth factor support allowed, but must not have received within 7 days prior to laboratory testing); Absolute lymphocyte count (ALC) ≥0.7×10⁹/L; Platelets ≥100×10⁹/L (no transfusion support within 7 days prior to laboratory testing); Hemoglobin ≥90 g/L (no RBC transfusion within 7 days prior to laboratory testing; recombinant human erythropoietin allowed); Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN); Total serum bilirubin ≤2×ULN; ALT and AST may be extended to ≤5×ULN if abnormalities are determined by the investigator to be due to disease (e.g., hepatic metastases or biliary obstruction) or Gilbert's syndrome; Renal function: Creatinine clearance (CrCl) ≥50 mL/min calculated by Cockcroft-Gault formula; Coagulation function: Fibrinogen ≥1.0 g/L; Activated partial thromboplastin time ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN; Oxygen saturation >91% (on room air); Left ventricular ejection fraction (LVEF) ≥50%;
Recovery from all toxicities related to prior treatment to acceptable baseline status, or recovery to normal or Grade 1 per NCI CTCAE 5.0, as determined by the investigator; except for toxicities not expected to increase safety risk of subsequent investigational product infusion, such as alopecia, vitiligo, etc.;
Agreement by subjects and their partners to use effective contraceptive methods (excluding rhythm method) from the time of informed consent signature until one year after CAR-T cell infusion;
Written informed consent on IRB/IEC-approved consent form obtained personally from the subject prior to initiation of any screening procedures.

Who cannot join

Other malignancies within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, or ductal carcinoma in situ of the breast after radical surgery;
Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer above the lower limit of detection of the quantitative assay at the study site; Hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA above the lower limit of detection of the quantitative assay at the study site; Human immunodeficiency virus (HIV) antibody positive; Positive syphilis test;
Patients with central nervous system metastases and/or other unstable central nervous system diseases (hemorrhage, active infarction, infection, etc.);
Receipt of live attenuated vaccine within 4 weeks prior to cell injection;
History of hypersensitivity to prior immunotherapy, allergy or intolerance to fludarabine, cyclophosphamide, albumin-bound paclitaxel conditioning regimen drugs, or tocilizumab, or allergy to components of the investigational product formulation, or history of other severe allergic reactions;
Poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) or clinically significant (e.g., active) cardiovascular disease, such as cerebrovascular accident (within 6 months prior to main informed consent signature), myocardial infarction (within 6 months prior to main informed consent signature), unstable angina, New York Heart Association (NYHA) Class II or greater congestive heart failure, or serious arrhythmia not controlled by medication or potentially affecting study treatment; Clinically significant abnormalities on ECG in 3 consecutive readings (at least 5 minutes apart each) or mean QTcB ≥450 ms;

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Other severe organic diseases or psychiatric disorders;
Chronic obstructive pulmonary disease, interstitial lung disease, or clinically significant abnormal pulmonary function test results;
Autoimmune diseases: History of autoimmune disease deemed unsuitable for this study by the investigator, such as systemic lupus erythematosus, vasculitis, infiltrative lung disease (subjects with vitiligo are excluded from this exclusion criterion);
Systemic corticosteroids (topical use allowed), hydroxyurea, immunomodulatory agents (e.g., α or γ interferon, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.) within 2 weeks prior to screening or planned use during the study (if long-term use exists);
Chemotherapy within 2 weeks prior to cell injection, immunotherapy within 4 weeks, radiotherapy within 12 weeks prior to infusion, or other antineoplastic agents with insufficient washout period of less than 5 half-lives;
Pregnant or lactating women, and female subjects planning pregnancy within 1 year after cell infusion;
Subjects with any concurrent medical condition or disease that the investigator determines may interfere with study conduct;
Receipt of other cellular or gene therapy products within 3 months prior to cell injection, or patients deemed unsuitable for enrollment by the investigator;
Patients whom the investigator determines will have difficulty completing all study visits or procedures (including follow-up period), or with insufficient compliance; or patients deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Weijia Fang, MD contact

86-0571-87237587

weijiafang@zju.edu.cn

Wenyu Wang contact

wywang0815@163.com

About this study

Read the detailed description

This is a single-arm, single-center, open-label, dose-escalation and expansion study to investigate the safety and tolerability, pharmacokinetics, and preliminary efficacy of the investigational product administered via intraperitoneal injection in adult patients with advanced solid tumors.

Dose-Escalation Phase： After providing informed consent, subjects will be screened for eligibility based on inclusion/exclusion criteria. Eligible subjects will receive KT032 treatment. Dose escalation will follow the "3+3" principle across three dose cohorts: 1.0×10⁶, 2.0×10⁶, and 3.0×10⁶ CAR-T cells/kg (for the highest dose cohort, dosing will be calculated based on 70 kg for subjects weighing >70 kg). Given the special nature of the cellular product, a ±20% variance in the actual administered dose is permitted for each cohort. This phase plans to enroll 12-18 subjects with single-dose administration.

Dose-Expansion Phase： Based on data from the dose-escalation phase, one optimal dose cohort will be selected to expand with 6 additional subjects. The specific expansion study plan and sample size will be determined according to preliminary safety, PK, and efficacy data obtained during the dose-escalation phase.

Conditions: Ovarian Cancer, Mesothelioma, Colon Cancer
Being tested: KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)
Keywords: CAR-T, Mesothelin-positive Advanced Solid Tumors
Medical subject headings: Ovarian Neoplasms, Mesothelioma, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)Biological
Lymphodepletion conditioning is required prior to administration of anti-MSLN chimeric antigen receptor autologous T cell injection (KT032).
KT032 is administered via intraperitoneal injection (10-30 ml cell injection solution by intraperitoneal bolus), 1 bag per dose, for a total of 1 dose. The investigational product dose will be determined based on the subject's body weight and the number of viable CAR-positive T cells. Dosing according to the pre-specified dose levels: 1.0×10⁶ CAR-T cells/kg, 2.0×10⁶ CAR-T cells/kg, and 3.0×10⁶ CAR-T cells/kg (for the highest dose cohort, if body weight exceeds 70 kg, dose calculation will be based on 70 kg). Given the special nature of cell products, an actual dosing variation of ±20% is permitted for each dose cohort.

Study groups in NCT07420010
Study group	Role	What they receive
KT032：1.0×10⁶ CAR-T cells/kg	Experimental	Not described Receives: Biological: KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)
KT032：2.0×10⁶ CAR-T cells/kg	Experimental	Not described Receives: Biological: KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)
KT032：3.0×10⁶ CAR-T cells/kg	Experimental	Not described Receives: Biological: KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-Limiting Toxicity（DLT）
Safety
Measured: 28 days
Maximal Tolerable Dose（MTD）
tolerability evaluation
Measured: 28 days
Adverse Event（AE）
Incidence rate
Measured: Disease progression, withdrawal from the study, death, or 2 years following cell administration, whichever occurs first
Serious Adverse Event（SAE）
Incidence rate
Measured: Disease progression, withdrawal from the study, death, or 2 years following cell administration, whichever occurs first
Adverse Event of Special Interest （ AESI）
Incidence rate
Measured: Disease progression, withdrawal from the study, death, or 2 years following cell administration, whichever occurs first

Secondary outcomes (6)

PK
CAR-T cells in peripheral blood were analyzed by flow cytometry, and CAR-T copy numbers in peripheral blood were quantified by quantitative PCR (qPCR); patients were followed until CAR-T cells and CAR-T copy numbers in peripheral blood were below the lower limit of quantification (LLOQ) in two consecutive assessments.
Measured: 2 years
Antitumor efficacy-Objective response rate (ORR)
Proportion of patients with Best Overall Response(BOR) of PR or CR
Measured: 2 years
Disease Control Rate (DCR)
Proportion of patients with BOR of PR, CR, or SD
Measured: 2 years
Duration of Response (DOR)
Time interval from first documented CR or PR to first documented PD or death from any cause;
Measured: 2 years
Progression-Free Survival (PFS)
Time from initiation of KT032 cell therapy to first disease progression or death from any cause, whichever occurs first
Measured: 2 years
Overall Survival (OS)
Time from initiation of KT032 cell therapy to death (from any cause)
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202631 Dec 2028

First posted19 Feb 2026
Study start15 Mar 2026 (estimated)
Primary completion31 Dec 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 Ovarian CancerStudies 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: Early Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07420010
Sponsor's protocol ID: KTZY001
Status last verified: Feb 2026
First submitted: 12 Feb 2026
Last updated: 19 Feb 2026
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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of KT032 Cell Injection in Patients With Mesothelin-positive Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT07420010
Acronym / sponsor ID: KTZY001
Conditions: Ovarian Cancer, Mesothelioma, Colon Cancer
Keywords: CAR-T, Mesothelin-positive Advanced Solid Tumors
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Weijia Fang, MDUniversity, hospital or other
Study start: 15 Mar 2026 (estimated)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 19 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
KT032：1.0×10⁶ CAR-T cells/kg	Experimental	Biological: KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)
KT032：2.0×10⁶ CAR-T cells/kg	Experimental	Biological: KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)
KT032：3.0×10⁶ CAR-T cells/kg	Experimental	Biological: KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Aged 18 to 75 years (inclusive), any gender;
Histopathologically confirmed diagnosis of advanced solid tumors (including but not limited to ovarian cancer, mesothelioma, colon cancer, etc.), with peritoneal or intraperitoneal metastasis as the primary disease manifestation;
Progression or intolerance to prior systemic standard-of-care treatment according to guidelines (systemic therapy includes but is not limited to systemic chemotherapy, molecular targeted therapy, etc.), and unsuitable for surgery or local treatment (including ablation therapy, interventional therapy, and radiotherapy); specifically: Ovarian cancer: Recurrence during or within 6 months after second-line or later platinum-based chemotherapy; Mesothelioma: Failure of, intolerance to, or ineligibility for at least first-line therapy; Colon cancer: Failure of, intolerance to, or ineligibility for at least third-line therapy;
Presence of at least one measurable lesion per RECIST 1.1 criteria;
MSLN expression positivity in tumor tissue detected by immunohistochemistry (IHC), defined as IHC ≥2+ (i.e., ≥26% positive tumor cells stained); subjects must undergo fresh tumor tissue biopsy; if biopsy is not feasible, at least 5 archived tumor tissue slides collected within one year must be provided (if multiple tumor tissue collections exist, the most recent sample is preferred);

Key exclusion criteria (15 listed)

Other malignancies within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, or ductal carcinoma in situ of the breast after radical surgery;
Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer above the lower limit of detection of the quantitative assay at the study site; Hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA above the lower limit of detection of the quantitative assay at the study site; Human immunodeficiency virus (HIV) antibody positive; Positive syphilis test;
Patients with central nervous system metastases and/or other unstable central nervous system diseases (hemorrhage, active infarction, infection, etc.);
Receipt of live attenuated vaccine within 4 weeks prior to cell injection;
History of hypersensitivity to prior immunotherapy, allergy or intolerance to fludarabine, cyclophosphamide, albumin-bound paclitaxel conditioning regimen drugs, or tocilizumab, or allergy to components of the investigational product formulation, or history of other severe 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
KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)Lymphodepletion conditioning is required prior to administration of anti-MSLN chimeric antigen receptor autologous T cell injection (KT032). KT032 is administered via intraperitoneal injection (10-30 ml cell injection solution by intraperitoneal bolus), 1 bag per dose, for a total of 1 dose. The investigational product dose will be determined based on the subject's body weight and the number of viable CAR-positive T cells. Dosing according to the pre-specified dose levels: 1.0×10⁶ CAR-T cells/kg, 2.0×10⁶ CAR-T cells/kg, and 3.0×10⁶ CAR-T cells/kg (for the highest dose cohort, if body weight exceeds 70 kg, dose calculation will be based on 70 kg). Given the special nature of cell products, an actual dosing variation of ±20% is permitted for each dose cohort.	Biological	KT032：1.0×10⁶ CAR-T cells/kg, KT032：2.0×10⁶ CAR-T cells/kg, KT032：3.0×10⁶ CAR-T cells/kg

Primary outcome

Dose-Limiting Toxicity（DLT）
Time frame: 28 days
Safety
Maximal Tolerable Dose（MTD）
Time frame: 28 days
tolerability evaluation
Adverse Event（AE）
Time frame: Disease progression, withdrawal from the study, death, or 2 years following cell administration, whichever occurs first
Incidence rate
Serious Adverse Event（SAE）
Time frame: Disease progression, withdrawal from the study, death, or 2 years following cell administration, whichever occurs first
Incidence rate
Adverse Event of Special Interest （ AESI）
Time frame: Disease progression, withdrawal from the study, death, or 2 years following cell administration, whichever occurs first
Incidence rate

6 secondary outcomes

PK
Time frame: 2 years
Antitumor efficacy-Objective response rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of Response (DOR)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 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 19 Feb 2026.

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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, MD contact

86-0571-87237587

weijiafang@zju.edu.cn

Wenyu Wang contact

wywang0815@163.com

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing KT032(anti-MSLN chimeric antigen receptor autologous T cell injection) in people with Ovarian Cancer and Mesothelioma, run by Weijia Fang, MD.

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 14 inclusion and 15 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: opening soon, as of the sponsor's last update on 19 Feb 2026. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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, MD (86-0571-87237587, weijiafang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity（DLT） (time frame: 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07420010.

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 19 Feb 2026.