Able to provide written informed consent.
Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Gastric and Esophageal Cancer, Ovarian Cancer, Mesothelioma, Breast Cancer, or Head and Neck Cancer and in the Investigator’s opinion the subject is high risk for incurable relapse within two years.
Age ≥ 18 years
Subjects are germline HLA-A*02 heterozygous confirmed by HLA typing.
Primary tumor tissue showing LOH of HLA-A*02 by NGS.
Adequate bone marrow reserve, hematological, renal and hepatic function defined as:
Hemoglobin > 9.0 g/dL;
ANC 800/µl;
Platelet count > 80,000/µl;
Serum Creatinine <1.5 x ULN;
Calculated Creatinine Clearance > 60 ml/min;
Total Serum Bilirubin < 2 x ULN;
ALT< 5 x ULN;
AST< 5 x ULN.
Eastern Cooperative Oncology Group (ECOG) performance status < 1.
Baseline oxygen saturation > 92% on room air.
No clinically significant pleural effusion.
History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
Prior allogeneic stem cell transplant.
Prior solid organ transplant.
Presence of any indwelling catheter or drain (e.g., percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal, pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
Subjects who have received any cancer therapy (investigational agent or not), including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 3 weeks of planned leukapheresis or 5 half-lives, whichever is shorter.
Has a diagnosis of immunodeficiency or autoimmune disease requiring continued systemic therapy (e.g., monoclonal antibody therapy).
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to completion of antibiotic course).
Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon sponsor agreement.
Known or suspected chronic, active Epstein Barr Virus (EBV).
Has known active history of or screened positive for Human Immunodeficiency Virus (HIV).
Has known active history of or screened positive for Hepatitis B (HBsAg positive) or C (anti-HCV positive).
Unstable angina, myocardial infarction, cardiac angioplasty or stenting, or any other significant cardiac disease within the last 6 months.
History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.
Requires supplemental home oxygen.
Significant pulmonary disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or obstructive pulmonary disease).
Females of childbearing potential who are pregnant or breastfeeding.
In the investigator’s judgement, the subject is unlikely to complete all protocol required study visits, including hospitalization, study visits and procedures, and follow up visits, or comply with the study requirements for participation.