Using tumor infiltrating lymphocytes to treat advanced breast cancer

A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Breast Cancer

This study is testing a new treatment using immune cells from tumors to see if it can help people with advanced breast cancer who haven't had success with other therapies.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Juncell Therapeutics (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, Prednisone, cyclophosphamide
• Locations: 1 site (Shanghai)
• Trial ID: NCT05142475 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced breast cancer. The approach involves expanding autologous TILs from tumor resections or biopsies and infusing them intravenously after a lymphodepletion treatment with hydroxychloroquine and cyclophosphamide. The goal is to evaluate how well this immunotherapy can work for patients who have not responded to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed advanced breast cancer who have failed standard treatment regimens.

Not a fit: Patients with early-stage breast cancer or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced breast cancer who have limited alternatives.

How similar studies have performed: Other studies using TIL therapy for various cancers have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age: 18 years to 75 years;
2. Histologically diagnosed as primary/relapsed/metastasized breast cancer;
3. Expected life-span more than 3 months;
4. Karnofsky≥60% or ECOG score 0-2;
5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
7. At least 1 evaluable tumor lesion;
8. Hematology and Chemistry（within 7 days prior to enrollment）:

   * Absolute count of white blood cells≥2.5×10\^9/L;
   * Absolute count of neutropils≥1.5×10\^9/L;
   * Absolute count of lymphocytes ≥0.7×109/L；
   * Platelet count≥100×10\^9；
   * hemoglobin≥90 g/L;
   * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);
   * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);
   * Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min;
   * Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN);
   * Totol bilirubin≤1.5×ULN;
9. no absolute or relative contraindications to operation or biopsy;
10. Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion；
11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;
12. Be able to understand and sign the informed consent document;
13. Be able to stick to follow-up visit plan and other requirements in the agreement.

Exclusion Criteria:

1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
3. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
4. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
5. Severe physical or mental diseases;
6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
9. Having received immunotherapy and developed irAE level greater than Level 3;
10. Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);
11. Females in pregnancy or lactation;
12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;
13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

Where this trial is running

Shanghai

• Shanghai Tenth People's Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: GC Clinical

Conditions Breast Cancer; Treatment Side Effects; Advanced Breast Cancer; Effects of Immunotherapy; Tumor Infiltrating Lymphocytes