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NCT05981001Recruiting

Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer

An Open-Label Phase I/II Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 1/2ClinicalTrials.govprocedure
Verified
Study focus
Disease/Condition
Breast Neoplasms
Drug/Device/Intervention
Surgery for harvesting tumor-draining lymph nodes
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Location
Guangzhou, China
Timeline & enrollment
Phase
Phase 1/2
Start date
Aug 01, 2023
End date
Apr 30, 2035
Enrollment
170 participants
Primary outcome

Phase I: Incidence of Dose-Limiting Toxicity (DLT),Phase I: Incidence of Grade≥3 Treatment-Emergent Adverse Event (TEAE),Phase II: Progression-Free-Survival (PFS)

Summary

RATIONALE: Patients with HER2-negative advanced breast cancer have limited choice on targeted
 therapies, and often show only modest responses to available immunotherapies. Adoptive cell
 therapy with tumor-infiltrating lymphocytes has difficulties in preparing enough cells from
 solid tumors and overcoming the exhaustion and dysfunction of T cells, which limit its
 clinical use. Tumor-draining lymph node-derived lymphocytes (LNLs) that have abundant
 tumor-specific T cells, rather than exhausted T cells, are easier to produce. It is not yet
 known whether LNL treatment is safe and effective in patients with advanced HER2-negative
 breast cancer.
 
 PURPOSE: This open-label phase I/II trial is to study the safety and efficacy of autologous
 LNL in patients with advanced HER2-negative breast cancer.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastMalignant neoplasm: Breast, unspecifiedBenign neoplasm of breastMalignant neoplasm: Central portion of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05981001
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05981001 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University and is currently Recruiting. The study focuses on Breast Neoplasms. Target enrollment is 170 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.