RecruitingEarly Phase 1NCT05856643

Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma

Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial


Sponsor

Shantou University Medical College

Enrollment

12 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called SZ011 — a type of targeted therapy that attaches to a protein called mesothelin on ovarian cancer cells — in women with ovarian cancer whose disease has returned or not responded to standard first-line treatment. **You may be eligible if...** - You are a woman between 18 and 80 years old - You have been diagnosed with ovarian cancer (epithelial type) confirmed by biopsy - Your cancer has relapsed or failed to respond to first-line chemotherapy - Your cancer cells test positive for the mesothelin protein - You have at least one measurable tumor and are in generally good health (KPS score 80 or higher) **You may NOT be eligible if...** - You have had another cancer in the past 5 years (except certain cured skin or cervical cancers) - You have serious problems with your liver, kidneys, blood cell counts, or heart - You are pregnant or breastfeeding - You have active autoimmune disease or uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSZ011 CAR-NK

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.


Locations(1)

Shantou University Medical College

Shantou, Guangdong, China

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NCT05856643


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