CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Precision Biotech Co., Ltd
About this trial
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, no gender restriction;
Histopathologically confirmed diagnosis of advanced, metastatic, or recurrent malignant tumors, primarily including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, lung cancer, and cholangiocarcinoma;
Failure of at least second-line standard treatment (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment options;
Immunohistochemical staining of tumor samples showing CEA positivity (clear membrane staining, positivity rate ≥ 10%) within the past 3 months; if the immunohistochemical result is older than 3 months (clear membrane staining, positivity rate ≥ 10%), serum CEA must exceed 10 µg/L;
Disqualifiers
Clinically symptomatic central nervous system metastasis or meningeal metastasis at screening, or other evidence indicating that central nervous system or meningeal metastasis has not been controlled, as determined by the investigator, making the patient unsuitable for enrollment.
Participation in another clinical trial within 1 month prior to screening.
Receipt of live attenuated vaccines within 4 weeks prior to screening.
Received the following anti-tumor treatments within 14 days or at least 5 half-lives (whichever is shorter) prior to screening: chemotherapy, targeted therapy, or other experimental drug treatments.
Trial design
Design model
Parallel
Treatments tested in this trial
CEA-targeted CAR-T cells
Biological/VaccineAdministration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
CEA-targeted CAR-T cells
Biological/VaccineAdministration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
CEA-targeted CAR-T cells
Biological/VaccineAdministration method: intraperitoneal infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
Treatment groups
108 Participants
are divided into 3 treatment groupsGroup A: Intravenous of CEA-targeted CAR-TExperimental treatment 1 intervention
Group B: Intrapleural infusion of CEA-targeted CAR-TExperimental treatment 1 intervention
Group C: Intraperitoneal infusion of CEA-targeted CAR-TExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety of CAR-T cell preparations in the treatment of CEA-positive advanced malignancies [Safety and Tolerability]
Incidence of adverse events during the study, evaluated per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Time frame
1 month2
Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CEA-positive advanced malignancies[Safety and Tolerability]
Dose-limiting toxicity after CEA CAR-T cell infusion
Time frame
1 monthSecondary outcomes
1
Assessing disease control rates of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]
Disease control rate: The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Time frame
From infusion through Month 32
To evaluate the efficacy of CAR-T cell preparations in CEA-positive advanced malignancies【Effectiveness】
Changes in serum tumor marker levels: CEA, CA19-9, CA-125, etc.
Time frame
From infusion through Month 33
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
Cmax: maximum observed level of circulating CAR-T cells in peripheral blood after infusion
Time frame
From infusion through Month 34
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
To determine the time to maximum observed level of circulating CAR-T cells (Tmax)
Time frame
From infusion through Month 3Other outcomes
1
Objective response rate (ORR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
Objective response rate includes：The proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Time frame
2 years2
Duration of Response (DOR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause
Time frame
2 years3
Progress-free survival(PFS) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
PFS will be assessed from the first CEA-CAR-T cell infusion to death from any cause or the first assessment of progression(Assessed based on RECIST criteria)
Time frame
2 years4
Overall survival(OS)of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
OS will be assessed from the first CEA-CAR-T cell infusion to death from any cause (Assessed by investigators based on IRECIST criteria)
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov