SCT-001 CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorShanghai Gynecologic Oncology Group
About this trial
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.
Eligibility criteria
Qualifiers
ECOG performance status score: 0~2 points or KPS score≥70 points;
Relapsed or refractory epithelial ovarian, fallopian tube and peritoneal cancer confirmed by histology or cytology and have failed, are intolerant or have no standard treatment after standard therapy;
Tumor tissue specimens or tumor samples can be obtained by tumor biopsy and other methods;
Immunohistochemistry (IHC) staining confirmed that the tumor cells had positive TAG-72 expression (positive definition: >). IHC staining intensity of 1% tumor cells ≥2+);
Disqualifiers
Those who are allergic to any component of SCT-001 CAR-T cell injection;
Received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc., or participated in other clinical trials and received 5 half-lives of therapeutic drugs within 4 weeks prior to the first use of the study drug (4 weeks or 5 half-lives, whichever is shorter);
Received treatment with traditional Chinese medicine or modern Chinese medicine preparations with anti-tumor indications in the label within 14 days before the first dose;
The adverse reactions of previous anti-tumor therapy have not recovered to NCI CTCAE v5.0 grade evaluation ≤ grade 1 (except for toxicity that the investigator judges has no safety risk such as alopecia);
Trial design
Treatments tested in this trial
- SCT-001 CAR-T cells
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov