This study is an open-label, dose-escalation, investigator-initiated phase I interventional clinical study. To evaluate the safety, tolerability and preliminary efficacy of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer, and to explore the pharmacokinetic characteristics, biomarker changes and immunogenicity of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer. In this study, two trial cohorts were set up, cohort 1 was the intraperitoneal route of administration, and the subjects enrolled in cohort 1 needed to meet the conditions for intraperitoneal administration ((1) the subject had a large amount of ascites, (2) the subject was suitable for peritoneal catheterization, (3) the subject had no severe abdominal adhesions, and (4) the subject agreed to undergo intraperitoneal surgical catheterization for intraperitoneal administration); Cohort 2 is the intravenous route.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
SCT-001 CAR-T cells are autologous-derived CAR-T cell products, which transduce second-generation CAR targeting TAG-72 into patient autologous T cells by lentiviral transfection, and knock out immunosuppressive related genes by CRISPR/Cas9 technology to enhance the anti-tumor function of CAR-T cells.
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Incidence of dose limiting toxicities (DLTs)
The incidence of of DLT event, which is defined as toxic events related to SCT-001 CAR-T cell injection that occur within the DLT observation period (28 days after CAR-T cell injection), including general adverse events graded according to NCI CTCAE v5.0, cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS).
Time frame: 28 days
Incidence of adverse events
Toxicity within 24 months after CAR-T cell injection will be graded according to the NCI CTCAE v5.0.
Time frame: 24 months
Change of CAR Copies
CAR Copies measured by qPCR (12 months after CAR-T infusion)
Time frame: 12 months
Objective response rate
The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria
Time frame: 12 months
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