NCT07179692

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1 lung-cancer

Timeline
25mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Sep 2025May 2028

First Submitted

Initial submission to the registry

September 11, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

September 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

September 11, 2025

Last Update Submit

September 28, 2025

Conditions

Lung CancerGastric CancerColon CancerRectal CancerEsophageal CancerPancreas Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

    1 month

  • 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

    1 month

Secondary Outcomes (5)

  • Assessing disease control rates of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]

    From infusion through Month 3

  • To evaluate the efficacy of CAR-T cell preparations in CEA-positive advanced malignancies【Effectiveness】

    From infusion through Month 3

  • To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】

    From infusion through Month 3

  • To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】

    From infusion through Month 3

  • To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】

    From infusion through Month 3

Other Outcomes (4)

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

    2 years

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

    2 years

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

    2 years

  • +1 more other outcomes

Study Arms (3)

Intravenous of CEA-targeted CAR-T

EXPERIMENTAL

Infusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg

Biological: CEA-targeted CAR-T cells

Intrapleural infusion of CEA-targeted CAR-T

EXPERIMENTAL

Infusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg

Biological: CEA-targeted CAR-T cells

Intraperitoneal infusion of CEA-targeted CAR-T

EXPERIMENTAL

Infusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg

Biological: CEA-targeted CAR-T cells

Interventions

CEA-targeted CAR-T cellsBIOLOGICAL

Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

Intravenous of CEA-targeted CAR-T

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • At least one evaluable lesion according to RECIST 1.1 criteria;
  • ECOG performance status of 0-2;
  • Expected survival of ≥ 12 weeks;
  • No severe psychiatric disorders;
  • Unless otherwise specified, the following important organ function criteria must be met:
  • Hematology: White blood cells \> 2.0 × 10\^9/L, neutrophils \> 0.8 × 10\^9/L, lymphocytes \> 0.5 × 10\^9/L, platelets \> 50 × 10\^9/L, hemoglobin \> 90 g/L;
  • Cardiac function: Echocardiogram shows ejection fraction ≥ 50%, ECG shows no significant abnormalities;
  • Renal function: Serum creatinine ≤ 2.0 × ULN;
  • Liver function: ALT and AST ≤ 3.0 × ULN (can be relaxed to ≤ 5.0 × ULN for patients with liver tumor infiltration);
  • Total bilirubin ≤ 2.0 × ULN;
  • Oxygen saturation \> 92% without supplemental oxygen;
  • +3 more criteria

You may not qualify if:

  • 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.
  • Active infection requiring systemic treatment or an uncontrolled infection.
  • Bowel obstruction, active gastrointestinal bleeding, or a history of major gastrointestinal bleeding within the last 3 months, or severe gastrointestinal conditions such as severe gastric or duodenal ulcers, severe ulcerative colitis, or other severe gastrointestinal inflammations.
  • Toxicity from prior anti-tumor treatments has not improved to baseline levels or ≤ grade 1, except for alopecia or peripheral neuropathy.
  • Any of the following cardiac conditions:
  • New York Heart Association (NYHA) Class III or IV congestive heart failure;
  • Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to enrollment;
  • Clinically significant ventricular arrhythmias, or history of unexplained syncope (excluding cases due to vasovagal or dehydration);
  • Severe non-ischemic cardiomyopathy.
  • Active autoimmune diseases or other conditions requiring long-term use of immunosuppressive therapy.
  • History of another malignancy within the past 3 years, excluding treated and stable 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 above the normal range; positive for hepatitis C virus (HCV) antibodies with peripheral blood HCV RNA levels above the normal range; positive for HIV antibodies; or positive for syphilis testing.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 901 Hospital of Joint Logistics Support Force of People Liberation Army

Hefei, Anhui, 230031, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsStomach NeoplasmsColonic NeoplasmsRectal NeoplasmsEsophageal NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Donglai Lv, MD

    The 901 Hospital of Joint Logistics Support Force of People Liberation Army

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donglai Lv, MD

CONTACT

+86 13655600090lvxunhuan@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 18, 2025

Study Start

September 12, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)