OncoMatch/Clinical Trials/NCT05981001
Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer
Is NCT05981001 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for breast neoplasms.
Treatment: Cyclophosphamide · Fludarabine · Tumor-draining lymph node-derived lymphocyte (LNL) · Interleukin-2 · Camrelizumab · Nab-paclitaxel · Gemcitabine · Carboplatin — 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.
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
Allowed: ER 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
Allowed: PD-L1 (CD274) expression
biopsy from a locally advanced or recurrent inoperable or metastatic tumor lesion for pathological examination of molecular subtype and PD-L1 expression
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: hormonal therapy — 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, or are appropriate candidates for chemotherapy.
Cannot have received: adoptive cell therapy
Have not received any prior adoptive cell therapy.
Cannot have received: chemotherapy or immune checkpoint inhibitor intended to be used in this study
Exception: Participants who received the same chemotherapeutic drugs and/or immune checkpoint inhibitor in the (neo)adjuvant setting as in this study are eligible, only if ≥12 months have elapsed between the completion of treatment with curative intent and the enrollment of this study.
Have not received the chemotherapeutic drugs and immune checkpoint inhibitor intended to be used in this study in the prior treatments for the Stage IIIB, IIIC or IV breast cancer. Participants who received the same chemotherapeutic drugs and/or immune checkpoint inhibitor in the (neo)adjuvant setting as in this study are eligible, only if ≥12 months have elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and the enrollment of this study.
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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