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NCT05981001
Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer
Phase 1, PHASE2 trial testing Surgery for harvesting tumor-draining lymph nodes in Breast Neoplasms in 170 participants. Currently enrolling.
30 April 2032
Quick facts
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 170 |
| Start date | 1 August 2023 |
| Primary completion | 30 April 2032 |
| Estimated completion | 30 April 2035 |
| Sites | 1 location across China |
Drugs / interventions tested
- Surgery for harvesting tumor-draining lymph nodes
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Tumor-draining lymph node-derived lymphocyte (LNL) — full drug profile →
- Interleukin-2
- Camrelizumab
- Nab-paclitaxel
- Gemcitabine (gemcitabine) — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Who can join
Adults 18 to 70, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Molecular Insights on Signaling Cascades in Breast Cancer: A Comprehensive Review.
Panda VK, Mishra B, Mahapatra S, Swain B, et al · · 2025 · cited 17× · PMID 39858015 · DOI 10.3390/cancers17020234 -
Targeting tumor-draining lymph node to overcome resistance to cancer immunotherapy: an update.
Lu J, Yu J, Xu T, Li Y, et al · · 2025 · PMID 41281945 · DOI 10.20517/cdr.2025.126
Verify or expand the search:
- PubMed search for NCT05981001
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Surgery for harvesting tumor-draining lymph nodes
Trials testing the same drug.
- NCT06121557 — Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer · Phase 1 · recruiting
Other recruiting trials for Breast Neoplasms
Currently open trials in the same condition.
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Other Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05981001 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Last refreshed: 8 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05981001.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing