Ovarian Epithelial CarcinomaEarly Phase 1NCT05856643
Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma
A Early Phase 1 study testing SZ011 CAR-NK in people with Ovarian Epithelial Carcinoma, run by Shantou University Medical College at 1 site in China.
Trial summary
This study was a single-center, open-label, investigator-initiated clinical trial (IIT) to observe and investigate the clinical safety and efficacy of SZ011 in the treatment of ovarian epithelial carcinoma Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Epithelial Carcinoma
- What is being tested?
- SZ011 CAR-NK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2024to 30 Dec 2025
- Phase
- Early 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 18-80;
- Histologically confirmed ovarian epithelial carcinoma;
- Ovarian cancer patients who have failed or relapsed after first-line treatment, with or without other treatments;
- At least one measurable lesion according to RECIST 1.1 ;
- Positive expression of mesothelin in ovarian cancer tumors;
- Functional status score (KPS) ≥80;
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- Expected survival ≥28 weeks;
- The function of important organs meets the following requirements: absolute neutrophil count ≥1.5×109/L; platelets count ≥50×109/L; hemoglobin ≥80g/L; serum albumin ≥2.5g/dL; bilirubin ≤1.5 times ULN; ALT and AST ≤3 times ULN; serum creatinine ≤1.5 times ULN;
- Able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
- The subject or their partner agrees to take the contraceptive measures recognized by the trial within 1 month after signing the informed consent form until the end of the study.
Who cannot join
- Exclusion criteria include those who have had other malignant tumors within the past 5 years, except for those who have been cured of basal cell carcinoma, cervical carcinoma in situ, and breast cancer that has not recurred for >3 years after radical surgery.
- Patients known to have central nervous system metastasis or leptomeningeal disease are excluded.
- Patients who have experienced arterial thromboembolic events (including myocardial infarction, cardiac arrest, cerebrovascular accident, ischemic stroke, deep venous thrombosis of CTCAE 5.0 grade ≥3) or a history of pulmonary embolism within 6 months prior to enrollment are excluded.
- Patients with a history of serious bleeding disorder within 6 months prior to screening, or those with a clear tendency to bleed (such as esophageal varices at risk of bleeding, active ulcer lesions, fecal occult blood >2+) as judged by the investigator, are excluded.
- Patients with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B or C virus infection, or other severe infectious diseases are excluded.
- Patients with clinically significant cardiovascular disease:
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- Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110mmHg) despite treatment;
- History of myocardial infarction or unstable angina pectoris within 6 months prior to enrollment;
- Congestive heart failure or NYHA class II heart failure;
- Severe symptomatic arrhythmia requiring medication, excluding asymptomatic atrial fibrillation that is controllable.
- Pregnant or lactating women are excluded.
- Those who have participated in or are currently participating in other clinical trials within the past three months are excluded.
- Patients considered unsuitable for this clinical trial by the investigator are excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shantou University Medical College
Shantou, Guangdong
About this study
Official title: Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial
This study was a single-center, open-label, investigator-initiated clinical trial (IIT) to observe and investigate the clinical safety and efficacy of SZ011 in the treatment of ovarian epithelial carcinoma
- Conditions
- Ovarian Epithelial Carcinoma
- Being tested
- SZ011 CAR-NK
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SZ011 CAR-NKDrug
In the escalation study, the minimum initial dose was 5.0×10^6 cells, then increased to 1.0×10^8, 2.0×10^8and 5.0×10^8 cells. The infusion is given every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SZ011 CAR-NK | Experimental | Not described Receives: Drug: SZ011 CAR-NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs)
To evaluate the safety of SZ011 CAR-NK Cells
Measured: Up to 6 months after infusion
Objective response rate (ORR)
To evaluate the ORR of SZ011 CAR-NK Cells
Measured: Up to 6 months after infusion
Overall survival (OS)
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Measured: Up to 6 months after infusion
Progression-free survival (PFS)
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Measured: Up to 6 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start13 Aug 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shantou University Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong ProCapZoom Biosciences Co., Ltd.
- Responsible party
- Principal investigator, Li Congzhu, Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856643
- Sponsor's protocol ID
- PCZCTP-230316-002
- Status last verified
- Aug 2024
- First submitted
- 3 May 2023
- Last updated
- 13 Aug 2024
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial
- ClinicalTrials.gov ID
- NCT05856643
- Acronym / sponsor ID
- PCZCTP-230316-002
- Conditions
- Ovarian Epithelial Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shantou University Medical CollegeUniversity, hospital or other
- Collaborators
- Guangdong ProCapZoom Biosciences Co., Ltd.
- Study start
- 13 Aug 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 May 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.
This study was a single-center, open-label, investigator-initiated clinical trial (IIT) to observe and investigate the clinical safety and efficacy of SZ011 in the treatment of ovarian epithelial carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SZ011 CAR-NK | Experimental | Drug: SZ011 CAR-NK |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Females aged 18-80;
- Histologically confirmed ovarian epithelial carcinoma;
- Ovarian cancer patients who have failed or relapsed after first-line treatment, with or without other treatments;
- At least one measurable lesion according to RECIST 1.1 ;
- Positive expression of mesothelin in ovarian cancer tumors;
Key exclusion criteria (13 listed)
- Exclusion criteria include those who have had other malignant tumors within the past 5 years, except for those who have been cured of basal cell carcinoma, cervical carcinoma in situ, and breast cancer that has not recurred for >3 years after radical surgery.
- Patients known to have central nervous system metastasis or leptomeningeal disease are excluded.
- Patients who have experienced arterial thromboembolic events (including myocardial infarction, cardiac arrest, cerebrovascular accident, ischemic stroke, deep venous thrombosis of CTCAE 5.0 grade ≥3) or a history of pulmonary embolism within 6 months prior to enrollment are excluded.
- Patients with a history of serious bleeding disorder within 6 months prior to screening, or those with a clear tendency to bleed (such as esophageal varices at risk of bleeding, active ulcer lesions, fecal occult blood >2+) as judged by the investigator, are excluded.
- Patients with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B or C virus infection, or other severe infectious diseases are excluded.
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 |
|---|---|---|
| SZ011 CAR-NKIn the escalation study, the minimum initial dose was 5.0×10^6 cells, then increased to 1.0×10^8, 2.0×10^8and 5.0×10^8 cells. The infusion is given every 2 weeks. | Drug | SZ011 CAR-NK |
Primary outcome
Number of Adverse Events (AEs)
Time frame: Up to 6 months after infusion
To evaluate the safety of SZ011 CAR-NK Cells
Objective response rate (ORR)
Time frame: Up to 6 months after infusion
To evaluate the ORR of SZ011 CAR-NK Cells
Overall survival (OS)
Time frame: Up to 6 months after infusion
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Progression-free survival (PFS)
Time frame: Up to 6 months after infusion
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SZ011 CAR-NK in people with Ovarian Epithelial Carcinoma, run by Shantou University Medical College 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 10 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 13 Aug 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ChongZhu Li, PhD (13923998618, czli2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (AEs) (time frame: Up to 6 months after infusion). The study lists 4 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 13 Aug 2024.