Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negati
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
| Condition(s) | Breast Neoplasms |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: In order to be eligible for participation in this trial, the participant must: 1. Have signed the informed consent to study participation. 2. Be a female subject and aged between 18 and 70 years. 3. Have locally advanced or recurrent inoperable HER2-negative breast cancer (Stage IIIB\~IIIC) which cannot be treated with curative intent OR have metastatic breast cancer (Stage IV). HER2-negative breast cancer is defined by the most recent ASCO/CAP guidelines. Participants should appear clinically stable in the opinion of the investigator. 4. Participants with estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive breast cancer have failed at least one line of hormonal therapy or CDK4/6 inhibitor, or are appropriate candidates for chemotherapy. Participa |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2023-08-01 |
| NCT ID | NCT05981001 |
| Official listing | https://clinicaltrials.gov/study/NCT05981001 |