A Phase I Clinical Study of Anti-CEA CAR-T (PTC13) Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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∙ Subjects must meet all the following criteria to be eligible for the study:

• 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.

• At least one evaluable lesion according to RECIST 1.1 criteria.

• ECOG score of 0-2 (Appendix 2).

• No severe psychiatric disorders.

• Unless specifically stated otherwise, subjects' major organ functions must meet the following conditions:

‣ Blood routine: WBC\>2.0×109/L, neutrophils\>0.8×109/L, lymphocytes\>0.5×109/L, platelets\>50×109/L, hemoglobin\>90g/L;

⁃ Cardiac function: Echocardiography indicating a left ventricular ejection fraction≥50%, and no significant abnormalities on electrocardiogram;

⁃ Renal function: Serum creatinine≤2.0×ULN;

⁃ Liver function: ALT and AST ≤3.0×ULN (may be relaxed to≤5.0×ULN if liver tumor infiltration is present);

⁃ Total bilirubin≤2.0×ULN;

⁃ Oxygen saturation\>92% without supplemental oxygen. 9. Eligible for apheresis or venous blood collection, with no contraindications for cell collection.

‣ 10\. Subjects agree to use reliable and effective contraceptive methods from signing the informed consent form until 1 year after receiving CAR-T cell infusion (excluding natural family planning methods).

‣ 11\. The patient or their guardian agree to participate in this clinical trial and signs the ICF, indicating an understanding of the trial's purpose and procedures and willingness to participate.

Locations
Other Locations
China
the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
RECRUITING
Hangzhou
Contact Information
Primary
Weijia Fang, MD
weijiafang@zju.edu.cn
86-0571-87237587
Backup
Yang Gao, MD
gaoyang954@zju.edu.cn
Time Frame
Start Date: 2024-07-24
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 18
Treatments
Experimental: Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13)
Intraperitoneal infusion of FAST CEA-targeted CAR-T cells (PTC13) by 4 dose levels
Sponsors
Leads: Weijia Fang, MD
Collaborators: Chongqing Precision Biotech Co., Ltd

This content was sourced from clinicaltrials.gov