Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06724835
Brief Summary:
A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT 293 (Nectin-4-CAR-T) in Nectin-4-positive advanced breast cancer
Detailed Description:
This study is a prospective, single-arm, open-label, single-dose dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy characteristics of XKDCT 293 (Nectin-4-CAR-T) cell preparation in subjects with Nectin-4-positive advanced breast cancer.
The study will enroll subjects with pathologically confirmed advanced breast cancer, positive Nectin-4 expression, who have previously received standard treatment, failed treatment or cannot tolerate it. Imaging examinations show evaluable tumor lesions.
The study included screening period, PBMC collection, baseline, lymphocyte pre-depletion chemotherapy , rest evaluation, cell transfusion, hospitalization observation period, routine follow-up period, and long-term follow-up period.
The study set up three dose groups, and adopted the classic 3+3 experimental design for dose escalation.
Main purpose:
(1)the safety and tolerability of XKDCT 293 in the treatment of nectin-4-positive advanced breast cancer
Secondary Purpose:
1. the cellular metabolic kinetics and pharmacodynamics of XKDCT 293 in the treatment of nectin-4 -positive advanced breast cancer ;
2. To preliminarily evaluate the efficacy of XKDCT 293 cell preparations in patients with advanced Nectin-4-positive breast cancer.
Study:
NCT06724835
Study Brief:
Protocol Section:
NCT06724835