Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT06904131

A Phase I Clinical Trial of CAR-T Cells for Advanced Gynecological Solid Tumors

Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2025-04-01

20

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Screening patients who meet the criteria for peripheral blood mononuclear cell (PBMC) isolation and cell preparation. Based on the status of cell preparation and mutual agreement between the researcher and the participant, the date of reinfusion (Day 0) is determined. From Day -5 to Day -3, the participant receives a conditioning regimen with cyclophosphamide and antithymocyte globulin. After recovery for two days (Day -2 and Day -1), on Day 0, the participant receives reinfusion of BZE2203 (dose determined according to the dose-escalation requirements). The safety observation period lasts for 28 days, and clinical efficacy is assessed from Day 28 to Day 34. After comprehensive judgment, the second course of cell therapy is selected. Follow-up observations and evaluations are conducted once every three months, with follow-up visits once a year and telephone follow-ups once every two months.

CONDITIONS

Official Title

A Phase I Clinical Trial of CAR-T Cells for Advanced Gynecological Solid Tumors

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 70 years (inclusive)
  • Diagnosed with gynecological solid tumors confirmed by histopathology
  • Tumor tissue sample showing MUC1 or MSLN expression rate of 50% or higher
  • PD-L1 positive expression with sample source within 2 years
  • Advanced gynecological solid tumors with failed or intolerant standard treatment and no effective options
  • Estimated survival time of 3 months or more
  • ECOG performance status score of 0 to 1 at screening and baseline
  • Adequate organ and bone marrow function as assessed by the researcher, including neutrophil count ≥1.5 × 10^9/L and lymphocyte count ≥0.5 × 10^9/L
  • Platelet count ≥90 × 10^9/L
  • Hemoglobin ≥90 g/L without recent blood transfusion or erythropoietin dependency within 7 days
  • Total bilirubin ≤2 times the upper limit of normal
  • Serum creatinine ≤1.5 times the upper limit of normal
  • Transaminase (AST, ALT) ≤2.5 times the upper limit of normal (or ≤5 times if liver metastasis present)
  • INR or prothrombin time ≤1.5 times the upper limit of normal
  • Pulmonary function with dyspnea grade ≤1 and SaO2 ≥91% on room air
  • Cardiac function with left ventricular ejection fraction (LVEF) ≥50% within 1 month of enrollment
Not Eligible

You will not qualify if you...

  • Received anti-tumor treatments not allowed by the protocol within 1 month before CAR-T infusion
  • Previous targeted therapy against MUC1 or MSLN, cellular therapy, gene therapy, CAR-T cell therapy, or any T cell therapy
  • Pregnant or breastfeeding women
  • Positive for AIDS virus, syphilis, hepatitis B surface antigen, or active hepatitis B or C infection
  • Any uncontrollable active infection, coagulopathy, or major disease
  • Active autoimmune diseases under treatment, organ transplantation, or long-term immunosuppressive drug use that cannot be stopped before enrollment
  • Severe cardiopulmonary insufficiency or recent major cardiovascular events
  • Confirmed brain metastasis or central nervous system disease
  • High risk of bleeding or perforation
  • Major surgery or significant trauma within 4 weeks before cell collection
  • Other malignant tumors within 3 years or concurrent (except certain skin or in situ cancers)
  • Any other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200090

Actively Recruiting

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Research Team

X

Xin Wu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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