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A Phase I Clinical Trial of CAR-T Cells for Advanced Gynecological Solid Tumors
Sponsor: Obstetrics & Gynecology Hospital of Fudan University
Summary
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.
Official title: A Phase I Clinical Trial of MUC1-targeted CAR-T Cells with PD1 Nanobody MSLN Dual-target for Advanced Gynecological Solid Tumors
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-05-11
Completion Date
2027-12-31
Last Updated
2025-04-01
Healthy Volunteers
No
Conditions
Interventions
Cell therapy with bispecific antibodies
The dose-escalation phase is designed with three predefined dose levels, following a "3+3 design" and progressing from low to high doses. The "3+3" dose-escalation scheme is as follows: if no dose-limiting toxicity (DLT) occurs in the three subjects at a given dose level during the observation period, the dose will be escalated to the next higher level. If one subject out of the initial three experiences DLT at a dose level, an additional three subjects will be enrolled at that dose level for further DLT observation. The dose level at which no more than one subject out of the final six subjects experiences DLT will be defined as the maximum tolerated dose (MTD).
Locations (1)
The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China