About this trial
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-CDH17 CAR-T cell injection in patients with CDH17-positive advanced malignant solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 70 years old (including cut-off value), gender is not limited.
Solid tumors that histological diagnosis of malignancy refractory to, or relapsing after standard therapy, including but not limited to colorectal cancer, gastric cancer, pancreatic cancer, biliary tract cancer.
At least one measurable lesion according to RECIST v1.1.
CDH17 should be positive confirmed by Immunohistochemistry/Immunocytochemistry (IHC/ICC) in tumor tissue samples.
Disqualifiers
Patients have received systemic therapy with cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives (which is shorter) prior to signing informed consent; Patients have received systemic glucocorticoids (prednisone at a dose of ≥10 mg per day or equivalent) or other immune-suppressive therapy within 2 weeks prior to signing informed consent; Patients have received systemic antitumor therapy with a biologic agent or other approved targeted small-molecule inhibitor within 1 week or five half-lives (which is shorter) prior to signing informed consent; Patients have received Chinese herbal medicine or Chinese patent medicine with anti-tumor indication within 1 week prior to signing informed consent.
Pregnant or lactating women.
Patients with hepatitis B surface antigen (HBsAg) positive. Patients who is hepatitis B core antibody (HBcAb) positive and the quantification of HBV DNA in peripheral blood is higher than the lower limit of detection. Patients who is hepatitis C virus (HCV) antibody positive and quantification of HCV DNA in peripheral blood is higher than the lower limit of detection. Patients with human immunodeficiency virus (HIV) antibody positive, or syphilis antibody positive.
The toxicities caused by the prior therapy (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) have not recovered to grade 1 according to CTCAE, except for hair loss and peripheral sensory nerve disorders.
Trial design
Single group
Treatments tested in this trial
Anti-CDH17 CAR-T cells
Biological/VaccineAnti-CDH17 CAR-T cell injection will be administered intravenously after lymphodepleting.
Treatment groups
Trial outcomes
Primary outcomes
Adverse Events (AEs)
Incidence and severity of adverse events.
Serious Adverse Events (SAEs)
Incidence and severity of serious adverse events.
Adverse Events of Special Interest (AESI)
Incidence and severity of adverse event of special interest.
Identification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs)
Incidence and severity of dose-limiting toxicities (DLTs) following infusion of CAR-T cell injection, at each dose level tested in dose escalation phase.
Secondary outcomes
Objective Response Rate (ORR)
The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Disease Control Rate (DCR)
Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Progression-Free Survival (PFS)
PFS is defined as the time from CAR-T infusion to the date of the disease progression or death from any cause.
Overall Survival (OS)
OS is defined as the time from CAR-T infusion to the date of death due to any cause.
Sponsors and contacts
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Shanghai Pudong Hospital
Lead sponsor
UTC Therapeutics Inc.
Collaborator