None listed
Conditions
Interventions
Genetic : 1. Study design
As a dose escalation, during the dose escalation phase of the study, up to three escalating dose levels of AB-201 will be tested. The dose escalation will initially begin wit
Sponsors
Konyang University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Signed the informed consent form (ICF). 2. Female, aged = 18 years at the time of signing the ICF. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histologically confirmed HER2-expressing breast cancer with =IHC 2+ within 6 months prior to subject enrolled. 5. Confirmed advanced/unresectable or metastatic HER2+ breast cancer that is refractory or intolerant to =3 lines of prior standard systemic therapy (pathologically documented). 6. Subjects with breast cancer must have previously treated =3 lines of systemic therapy. 7. Had an adequate systemic washout period defined as follows prior to AB-201 administration; - Major Surgery = 4 weeks. - Radiation therapy = 4 weeks (or =2 weeks for palliative stereotactic radiation therapy not involving the abdomen). - Autologous transplantation = 3 months. - Chemotherapy (including antibody-drug) = 3 weeks (or = 2 weeks for 5-fluorouracil-based agents, leucovorin agent, and/or weekly paclitaxel; or = 6 weeks for nitrosoureas or mitomycin C; or > 1 week for TKI approved for the treatment of breast or gastric/GEJ cancer - the baseline CT scan must be completed after TKI discontinuation). - Hormone therapy = 3 weeks. - Immunotherapy = 4 weeks. 8. Measurable disease according to RECIST v.1.1 criteria as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) (at least one measurable target lesion). 9. Oxygen saturation = 92% via pulse oximetry at room air rest. 10. Left Ventricular Ejection Fraction (LVEF) = 50% with no evidence of pericardial effusion as measured by echocardiogram (ECHO)/Multiple Gated Acquisition (MUGA) scan. 11. Adequate hematologic, renal, and hepatic function as demonstrated by baseline laboratory test values meeting the following requirements: - Absolute Neutrophil Count (ANC) = 1,000/? (1.0 x 10^9/L) - Platelets (PLT) = 75,000/? (75 x 10^9/L) - Hemoglobin = 8.0 g/dL (Transfusions are permitted up to 2 weeks prior to the first AB-201 dose and as needed during the treatment period). - Creatinine Clearance = 45 mL/min using the Cockcroft-Gault formula, or estimated Glomerular Filtration Rate (eGFR) =45 mL/min/1.73? according to the Modification of Diet in Renal Disease (MDRD) formula. - Total Bilirubin < 2.5 mg/dL (< 5 mg/dL for subjects with known Gilbert’s syndrome). - Hepatic Aminotransferases (AST/ALT/ALP) = 3 x ULN; Subjects with liver metastasis may have AST, ALT, ALP = 5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Active Central Nervous System (CNS) metastases or confirmed CNS involvement; however, subjects with a history of treated disease are eligible if they have remained in remission for at least 3 months and have had no changes in steroid dosage for at least 28 days prior to study enrollment. 2. Known past or current malignancy other than the target diagnosis for inclusion, with the following exceptions: a. Stage IB or lower cervical carcinoma. b. Non-invasive basal cell or squamous cell skin carcinoma. c. Non-invasive, superficial bladder cancer. d. Prostate cancer with a current PSA level 2 years. 3. Known clinically significant cardiac history, including: a. Unstable angina occurring within 6 months prior to signing the Informed Consent Form (ICF). b. Acute myocardial infarction within 6 months prior to signing the ICF. c. Congestive heart failure (New York Heart Association [NYHA] Class II, III, or IV). d. Impaired cardiac function as assessed by echocardiogram or MUGA scan (LVEF < 50%). e. Uncontrolled arrhythmia or uncontrolled hypertension. f. Heart valvular disease. 4. Unresolved toxicities from prior anti-cancer therapies that, in the opinion of the investigator, are clinically significant. 5. Ongoing, uncontrolled systemic infection requiring antibiotic, antifungal, or antiviral therapy. 6. History of active Human Immunodeficiency Virus (HIV) infection. 7. Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection based on laboratory tests conducted during screening. Subjects with HBV are eligible if the viral load is below the institutional Limit of Quantification (LOQ) and the subject is on stable viral suppression therapy. Subjects with HCV are eligible if they have completed curative antiviral treatment and the HCV RNA viral load is below the institutional LOQ. 8. Live vaccine administration is planned or required during the study treatment period. 9. History of sensitivity or intolerance to cyclophosphamide or fludarabine. 10. Female subjects of childbearing potential who are unable or unwilling to use adequate contraception (e.g., condoms, diaphragm, intrauterine device [IUD], combination hormonal oral contraceptives, or vasectomy of the male partner) during the study and for 6 months after the last dose of AB-201. 11. Currently pregnant or breastfeeding (breastfeeding must not be initiated within 6 months after the last dose of AB-201). 12. Any condition that may interfere with the assessment of safety or efficacy, or if the investigator deems the subject unsuitable for enrollment. 13. History or presence of clinically significant CNS disorders, such as seizure disorders (e.g., epilepsy), cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, Posterior Reversible Encephalopathy Syndrome (PRES), or autoimmune diseases with CNS involvement. 14. Any medical, psychological, familial, or sociological condition that, in the investigator’s opinion, may compromise the subject’s ability to receive human cell therapy products or comply with study requirements, including understanding and providing informed consent. 15. Severe disease progression or clinical deterioration within 2 weeks prior to lymphodepletion therapy that, in the investigator’s opinion, would impair the subject’s ability to receive human cell therapy products or comply with study requirements. 16. History of prior organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of AB-201;Concomitant Medication;Physical Examination;ECOG(Eastern Cooperative Oncology Group) Performance Status;Acute GvHD(Graft-vursus-Host Disease);Vital Sign;Laboratory Exam Test Findings | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR | — |
Countries
Korea, Republic of
Contacts
Public ContactDongho Kim
Konyang University Hospital
Outcome results
None listed