TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer

Phase 1

Recruiting

• Conditions: Breast Cancer; Breast Carcinoma; Breast Cancer Metastatic; Breast Cancer Triple Negative

• Registration Number: NCT06532812
• Lead Sponsor: Essen Biotech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Inclusion Criteria:<br><br> - Age: 16 years to 90 years<br><br> - Histologically diagnosed as primary/relapsed/metastasized brain glioma<br><br> - Expected life span more than 3 months<br><br> - Karnofsky=60% or ECOG score 0-2<br><br> - Test subjects have failed standard treatment regimens, or there are no standard<br> treatment regimens available.<br><br> - Test subjects must have tumor regions eligible for biopsy or resection, or malignant<br> body fluid where TILs can be isolated<br><br> - At least 1 evaluable tumor lesion<br><br> - Hematology and Chemistry(within 7 days prior to enrollment):<br><br> - Absolute count of white blood cells=2.5×10^9/L<br><br> - Absolute count of neutropils=1.5×10^9/L<br><br> - Absolute count of lymphocytes =0.7×109/L<br><br> - Platelet count=100×10^9<br><br> - hemoglobin=90 g/L<br><br> - Activated partial thromboplastin time (APTT) =1.5xULN (Unless received anticoagulant<br> therapy within the previous 3 days)<br><br> - International normalized ratio (INR) =1.5xULN (Unless received anticoagulant therapy<br> within the previous 3 days)<br><br> - Serum creatinine =1.5mg/dL(or =132.6µmol/L), or clearance rate=50mL/min<br><br> - Serum ALT/AST =3×ULN(subjects with liver metastasis =3×ULN)<br><br> - Totol bilirubin=1.5×ULN<br><br> - No absolute or relative contraindications to operation or biopsy<br><br> - Test subjects with child-bearing potential must be willing to practice approved<br> highly effective methods of contraception at the time of informed consent and<br> continue within 1 year after the completion of lymphodepletion<br><br> - Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and<br> biologics must cease 28 days before obtaining TILs<br><br> - Be able to understand and sign the informed consent document;<br><br> - Be able to stick to follow-up visit plan and other requirements in the agreement.<br><br>Exclusion Criteria:<br><br> - Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or<br> equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory<br> treatment<br><br> - Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of<br> the lung for carbon monoxide (DLCO) (calibrated) less than 40%<br><br> - Significant cardiovascular anomalies according to any of the following definitions:<br><br> - New York Heart Association (NYHA) Grade III or IV congestive heart failure,<br> clinically significant<br><br> - Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection<br> fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as<br> ventricular arrhythmia requiring clinical intervention, second-third degree<br> atrioventricular conductive block, etc.<br><br> - Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active<br> HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection<br> or Treponema pallidum antibody positive.<br><br> - Severe physical or mental diseases;<br><br> - Have a systemic active infection requiring treatment, or have positive blood<br> cultures(or imaging evidence of infection).<br><br> - Having been treated within a month or being treated now with other medicines, or<br> other biologic therapy, chemo-or radiotherapy.<br><br> - History of allergy to chemical compounds consisting of chemical and biological<br> substances resembling cell therapy.<br><br> - Having received immunotherapy and developed an irAE level greater than Level 3.<br><br> - Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below<br> (toxicity considered by the investigator as non-safety concerns like alopecia<br> excluded).<br><br> - Females in pregnancy or lactation. History of organ transplantation, allogeneic stem<br> cell transplantation, and renal replacement therapy.<br><br> - Researchers consider the test subject as having a history of other severe systemic<br> diseases, or other reasons inappropriate for the clinical study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR);Disease Control Rate (DCR);Duration of Response (DOR);Progression-Free Survival (PFS)