OncoMatch/Clinical Trials/NCT06121557
Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer
Is NCT06121557 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for breast neoplasms.
Treatment: Cyclophosphamide · Fludarabine · Tumor-draining lymph node-derived lymphocyte (LNL) · Interleukin-2 · Camrelizumab · Chemotherapeutic drug, ADC or PARP inhibitor — 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 phase I trial is mainly to study the safety of autologous LNL in patients with advanced HER2-negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
HER2-negative breast cancer is defined by the most recent ASCO/CAP guidelines
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
biopsy ... for pathological examination of molecular subtype and PD-L1 expression
Allowed: ESR1 positive
Participants with estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive breast cancer
Allowed: PR (PGR) positive
Participants with estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive breast cancer
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: hormonal therapy — for ER-positive and/or PR-positive breast cancer
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
Must have received: CDK4/6 inhibitor — for ER-positive and/or PR-positive breast cancer
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
Cannot have received: adoptive cell therapy
Have not received any prior adoptive cell therapy
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Lymphocyte count >0.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥90 g/L
Kidney function
Calculated creatinine clearance (CrCL) ≥45 mL/min OR creatinine ≤1.5×ULN
Liver function
AST and ALT ≤2.5×ULN (≤5×ULN for participants with liver metastases); ALP ≤2.5×ULN (≤5×ULN for participants with liver or bone metastases); Total bilirubin ≤1.5×ULN (≤3.0 mg/dL for participants with Gilbert's syndrome)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50%
Demonstrate adequate normal organ function: ... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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