Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria
1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell
Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally
advanced, or in the Investigator's opinion the subject is high risk for incurable relapse
within two years.
Part 1: Key Exclusion Criteria
1. 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.
2. Prior allogeneic stem cell transplant.
3. Prior solid organ transplant.
Part 2 : Key Inclusion Criteria
1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell
Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC)
that is metastatic, unresectable locally advanced, or in the Investigator's opinion
the subject is high risk for incurable relapse within two years.
2. Participants are germline HLA-A*02 heterozygous confirmed by HLA typing.
3. Primary tumor tissue showing LOH of HLA-A*02 by NGS testing.
4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.
Part 2: Key Exclusion Criteria
1. 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.
2. Prior allogeneic stem cell transplant.
3. Prior solid organ transplant.
4. Participants who have received any cancer therapy on any investigational therapy for
any indication, including but not limited to chemotherapy, small molecules, monoclonal
antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned
apheresis or 3 half-lives, whichever is shorter.
5. 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 Intravenous (IV)
antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of
antibiotic course).
6. Has known active central nervous system metastases. Subjects with previously treated
brain metastases may participate upon medical monitor agreement.
7. In the Investigator's judgement, any other condition or reason the subject would not
complete the required study visits and procedures, and follow up visits, or comply
with the study requirements for participation.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/14/2024. Questions regarding updates should be directed to the study team contact.