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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06121557 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior adoptive cell therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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