NCT06724835

Treating Nectin-4-positive Advanced Breast Cancer with XKDCT293 (Nectin-4-CAR-T)

A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial of the Safety, Efficacy, and Pharmacokinetics of XKDCT293 (Nectin-4-CAR-T) in Nectin-4-positive Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shenzhen Celconta Life Science Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	XKDCT293	Autologous targeted Nectin4 chimeric antigen receptor T cell injection
OTHER	CAR-T cell	Nectin-4-CAR-T

Timeline

• Start date: 2024-03-11
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-12-09
• Last updated: 2024-12-09

Locations

1 site across 1 country: China