Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeijia Fang, MD
About this trial
This is a phase I clinical study to evaluate the safety and tolerability of FAST targeted chimeric antigen receptor (CAR)-T cells (PTC13) in patients with carcinoembryonic antigen (CEA)-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of FAST CAR-T (PTC13) and phase II Recommended dose.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years, regardless of gender.
Diagnosed with advanced, metastatic, or recurrent malignant tumors confirmed by histology or pathology, primarily including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, lung cancer, or cholangiocarcinoma.
Failure of at least second-line standard therapy (due to disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or a lack of effective treatment options.
Immunohistochemical staining of tumor samples within 3 months confirming CEA positivity (distinct membrane staining with a positivity rate of≥10%); if the immunohistochemical result of the tumor sample is more than 3 months old at the time of screening (distinct membrane staining with a positivity rate of≥10%), the patient's serum CEA must exceed 10µg/L.
Disqualifiers
Clinically symptomatic central nervous system or leptomeningeal metastasis at the time of screening, or other evidence suggesting that central nervous system or leptomeningeal metastases are not controlled, as judged unsuitable for inclusion by the investigator.
Participation in another clinical study within 1 month prior to screening.
Receipt of live attenuated vaccines within 4 weeks prior to screening.
Receipt of the following anti-tumor treatments before screening: Chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter).
Trial design
Design model
Single group
Treatments tested in this trial
Intraperitoneal infusion of FAST CEA-targeted CAR-T
Biological/VaccineIntraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13); Subjects will be treated with Fludarabine and Cyclophosphamide based lymphodepleting chemotherapy before CAR-T cell infusion.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse events after CEA-CAR-T cells infusion
Incidence and proportion of adverse events during the trial (evaluated per Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0) and ASTCT criteria)
Time frame
28 days2
Obtain the maximum tolerated dose of CEA-CAR-T cells
Dose-limiting toxicity after cell infusion
Time frame
28 daysSecondary outcomes
1
Disease control rate of CAR-T cell preparations in CEA-positive advanced malignancies
including complete response (CR), partial response (PR) and stable disease (SD)
Time frame
3 months2
Changes in serum tumor markers of CAR-T cell preparations in CEA-positive advanced malignancies
Tumor markers including CEA、 CA199、 CA125
Time frame
3 months3
Pharmacokinetic of CAR-T cells (Cmax)
The highest concentration of CAR-T cells in peripheral blood post-administration.
Time frame
1 year4
Pharmacokinetic of CAR-T cells (Tmax)
The time to reach the highest concentration
Time frame
1 yearOther outcomes
1
Objective response rate (ORR) of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies
Objective response rate includes：CR、PR
Time frame
1 year2
Duration of Response (DOR) of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies
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
1 year3
Progress-free survival(PFS) of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies
PFS will be assessed from the first CEA-CAR-T cell infusion to death from any cause or the first assessment of progression.
Time frame
1 year4
Overall survival(OS)of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies
OS will be assessed from the first CEA-CAR-T cell infusion to death from any cause
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Weijia Fang, MD
Lead sponsor
Zhejiang University
Sponsor institution
Chongqing Precision Biotech Co., Ltd
Collaborator
Source ClinicalTrials.gov