Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06903117

Anti-CEA CAR-T for Advanced CEA-Positive Lung Carcinoma

Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-04-03

60

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Lung cancer is the leading cause of morbidity and mortality in the world, of which 80%-85% are non-small cell lung cancer (NSCLC). Most patients with NSCLC are at the advanced stage of diagnosis and have a poor prognosis. The 5-year survival rate of stage III patients is about 15%, the 5-year survival rate of stage IV patients is less than 5%, and the median survival time is only 7 months. CEACAM5 (CEA), also known as CD66e, is a classic tumor marker that has been used as a marker for many types of tumors for 50 years. It is mainly expressed in lung cancer, esophageal cancer, bile duct cancer, colorectal cancer, gastric cancer and other tumor types. In previous CAR-T-related clinical trials targeting CEA, the research team found that CAR-T cell preparations had a certain killing effect on CEA positive tumor cells. At the same time, CAR-T cell preparations cannot be sustained for a long time in the body, which is also a key factor restricting the anti-tumor effect of CAR-T cells in the body. To solve this problem, the killing ability and survival ability of CAR-T cell preparations on tumor cells in vitro and in vivo were improved by optimizing CAR structure and improving culture mode.

CONDITIONS

Official Title

Anti-CEA CAR-T for Advanced CEA-Positive Lung Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Histologically or pathologically confirmed advanced, metastatic, or recurrent lung cancer including non-small cell and small cell types
  • Progression or intolerance after at least second-line standard therapy; targeted therapy required for driver gene positive NSCLC, platinum chemotherapy for driver negative NSCLC or small cell lung cancer
  • CEA positive tumor confirmed by immunohistochemistry within 3 months (membrane staining, positive rate 60;10%) or serum CEA above 10ug/L if older than 3 months
  • At least one measurable lesion by RECIST 1.1 criteria (extranodal lesion 60;10mm, nodal short diameter 60;15mm)
  • ECOG performance status 0-2
  • Expected survival time greater than 12 weeks
  • No serious mental disorders
  • Adequate vital organ function including blood counts, cardiac, renal, liver functions, and oxygen saturation above 92% without oxygen
  • Eligible for blood collection without contraindications
  • Willing to use effective contraception for 1 year after CAR T infusion
  • Signed informed consent and willingness to participate in the trial
Not Eligible

You will not qualify if you...

  • Central nervous system or meningeal metastasis with symptoms or uncontrolled status
  • Participation in other clinical trials within 1 month prior to screening
  • Received live attenuated vaccine within 4 weeks before screening
  • Received chemotherapy, targeted therapy, or investigational agents within 14 days or 5 half-lives prior to screening
  • Active or uncontrolled infections needing systemic treatment
  • Tumor causing trachea or large blood vessel compression with high risk
  • Large uncontrollable fluid accumulation in body cavities
  • Toxicity from prior antitumor therapy not recovered to baseline or 60; grade 1 (except alopecia or neuropathy)
  • Severe heart conditions including NYHA III-IV heart failure, recent myocardial infarction or CABG within 6 months, serious arrhythmias, or severe cardiomyopathy
  • Active autoimmune diseases or requiring long-term immunosuppressive treatment
  • Other untreated cancers within 3 years except cervical carcinoma in situ and skin basal cell carcinoma
  • Positive for hepatitis B or C with abnormal viral loads, HIV, or syphilis
  • Pregnant or breastfeeding women
  • Any other condition judged unsuitable by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Changzheng Hospital, Naval Military Medical University, Shanghai, China

Shanghai, China, 200003

Actively Recruiting

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Research Team

H

Hao Tang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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