Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fate Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors
2. Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors
3. Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tumors
4. Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
5. Presence of measurable disease by RECIST 1.1
6. Life expectancy of at least 3 months.
7. Provision of signed and dated informed consent form (ICF).
8. Stated willingness to comply with study procedures and duration.
You may not be if
1. Females of reproductive potential that are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study.
2. Eastern Cooperative Oncology Group (ECOG) performance status \>2.
3. Evidence of insufficient organ function as determined by the protocol.
4. Receipt of any biological therapy, chemotherapy, or radiation within 1 week of the Screening Visit and at least 3 weeks prior to Day 1, except for patients receiving maintenance trastuzumab.
5. Have central nervous system disease (CNS) as follows:
1. Dose Escalation Cohorts: Active CNS disease, including history of CNS metastases.
2. MTD/MFD Expansion Cohorts: CNS disease, including history of CNS metastases, that was not stable during the last 6 months.
6. Myocardial infarction (MI) within 6 months of Screening Visit.
7. Severe asthma.
8. Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29.
9. Uncontrolled infections.
10. Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.
Clareo Health | FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
