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

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 pati

Trial Details

NCT ID
NCT06121557
Phase
PHASE1
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Surgery for harvesting tumor-draining lymph nodes
  • Cyclophosphamide
  • Fludarabine
  • Tumor-draining lymph node-derived lymphocyte (LNL)
  • Interleukin-2
  • Camrelizumab
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • In order to be eligible for participation in this trial, the participant must:
  • Have signed the informed consent to study participation.
  • Be a female subject and aged between 18 and 70 years.
  • Have locally advanced or recurrent inoperable HER2-negative breast cancer (Stage IIIB\~IIIC) which cannot be treated with curative intent OR have m…

For full eligibility, visit ClinicalTrials.gov.

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