Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors

NCT06821048 | Recruiting Phase 1

• 1 other identifier: PBC039V1.4
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stomach Cancer; Pancreatic Cancer; Metastatic Cancer; Colorectal Cancer

Keywords

FAST CAR-T; CEA-positive advanced malignant solid tumors

Outcome Measures

Primary Outcomes (2)

• 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)

  28 days

• Obtain the maximum tolerated dose of CEA-CAR-T cells

  Dose-limiting toxicity after cell infusion

  28 days

Secondary Outcomes (6)

• Disease control rate of CAR-T cell preparations in CEA-positive advanced malignancies

  3 months

• Changes in serum tumor markers of CAR-T cell preparations in CEA-positive advanced malignancies

  3 months

• Pharmacokinetic of CAR-T cells (Cmax)

  1 year

• Pharmacokinetic of CAR-T cells (Tmax)

  1 year

• Pharmacokinetic of CAR-T cells (AUC28d/90d)

  1 year

Other Outcomes (8)

• Objective response rate (ORR) of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies

  1 year

• Duration of Response (DOR) of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies

  1 year

• Progress-free survival(PFS) of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies

  1 year

Study Arms (1)

Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13)

EXPERIMENTAL

Intraperitoneal infusion of FAST CEA-targeted CAR-T cells (PTC13) by 4 dose levels

Biological: Intraperitoneal infusion of FAST CEA-targeted CAR-T

Interventions

Intraperitoneal infusion of FAST CEA-targeted CAR-T BIOLOGICAL

Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13); Subjects will be treated with Fludarabine and Cyclophosphamide based lymphodepleting chemotherapy before CAR-T cell infusion.

Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from the study:
• 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).
• Presence of active or uncontrolled infections requiring systemic treatment.
• Patients with intestinal obstruction, active gastrointestinal bleeding, a history of major gastrointestinal bleeding within 3 months, severe gastroduodenal ulcers, or severe gastrointestinal inflammation such as ulcerative colitis.
• Toxicity from previous anti-tumor therapy that has not improved to baseline levels or≤Grade 1, except for alopecia or peripheral neuropathy.
• Presence of any of the following cardiac conditions:
• New York Heart Association (NYHA) Stage III or IV congestive heart failure;
• Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to enrollment;
• Clinically significant ventricular arrhythmia or history of unexplained syncope (excluding vasovagal or dehydration-related causes);
• History of severe non-ischemic cardiomyopathy.
• Presence of active autoimmune diseases or other conditions requiring long-term immunosuppressive therapy.
• Diagnosis of another untreated malignancy within the past 3 years, except for in situ cervical cancer or basal cell carcinoma of the skin.
• Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA levels exceeding the normal range; positive for hepatitis C virus (HCV) antibodies with peripheral blood HCV RNA levels exceeding the normal range; positive for human immunodeficiency virus (HIV) antibodies; or positive syphilis test.

Sponsors & Collaborators

• Weijia Fang, MD: lead
• Chongqing Precision Biotech Co., Ltd: collaborator

Study Sites (1)

the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Weijia Fang, MD

CONTACT

86-0571-87237587; weijiafang@zju.edu.cn

Yang Gao, MD

CONTACT

gaoyang954@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 11, 2025
• Study Start: July 24, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CN (1)