This is a First-in-Human, open-label, early dose-escalation clinical study to evaluate the safety and preliminary efficacy of GC511B CAR T cell injection in Adult with DLL3+ r/r SCLC trial participants.
1.Trial articipant must be ≥ 18 years and ≤75 years of age at the time of signing the ICF.
2.ECOG performance status 0-2.
3.Life expectancy ≥ 12 weeks.
4.At least 1 TL meeting RECIST v1.1 at screening. Tumor assessment by CT scan or MRI must be performed within 28 days prior to apheresis.
1.Pregnant or breastfeeding females, or female trial participants with a positive pregnancy test result during the screening period (females not of childbearing potential are not required to receive a pregnancy test, such as metrectomy and/or bilateral oophorectomy, or amenorrhea for ≥ 12 months).
2. Trial participants who have received a live vaccine within 4 weeks prior to initiation of apheresis or who plan to receive any vaccine (other than coronavirus disease 2019 vaccine) during the study.
3.Trial participants has a history of other acquired or congenital immunodeficiency; trial participants received organ transplant or bone marrow transplant.
4.The trial participants has a serious arterial/venous thromboembolic event or cerebrovascular accident within 6 months before apheresis, such as deep venous thrombosis (excluding asymptomatic and untreated muscle venous thrombosis), pulmonary embolism, cerebral infarction, cerebral hemorrhage and except for myocardial infarction that is asymptomatic and does not require clinical intervention.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborator