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Home Precision Bio's CEA-Targeted CAR-T Therapy C-13-X Reports 71.1% One-Year Overall Survival in Heavily Pretreated Metastatic NSCLC Patients

Precision Bio's CEA-Targeted CAR-T Therapy C-13-X Reports 71.1% One-Year Overall Survival in Heavily Pretreated Metastatic NSCLC Patients

Jun 06, 2025 11:34 CST Updated 11:34
Precision Biotech

Gene and Cell Therapy Developer

Disclaimer: Due to limited expertise, errors are inevitable, and some information may not be the most up-to-date. Feel free to point out in the comments. This article is only an introduction to medical and health-related drugs, not a recommendation of treatment plans (if involved); it does not constitute any investment advice.


The CAR-T product precisely targeting CEA, developed by Chongqing Precision Biotech Co., Ltd., has undergone several iterations and updates. It has achieved remarkable results in colorectal cancer, which ranks third in incidence and second in mortality. In 2024, it was orally presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. This time, the CEA CAR-T therapy is once again aimed at lung cancer, a solid tumor with high incidence, complex treatment, and significant prognostic challenges, striving to explore more effective treatment strategies. The debut performance of C-13-X was unveiled globally through an oral presentation at ASCO on June 2, 2025, as the only CAR-T treatment technology for lung cancer presented at the venue.
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C-13-X CAR-T Product is Developed by Chongqing Precision Biotech Co., Ltd.World's First CAR-T Cell Therapy Targeting Carcinoembryonic Antigen (CEA), this time announcing breakthrough data from its Phase I clinical trial for the treatment of advanced metastatic non-small cell lung cancer (NSCLC). The study was led by Professors Wei Shuang and Wei Jia from Tongji Hospital affiliated with Huazhong University of Science and Technology / Shanxi Bethune Hospital (Tongji Shanxi Hospital). The results showed that in the extremely advanced NSCLC population, who had failed multiple previous lines of therapy, C-13-X achieved exciting results.71.1% one-year overall survival (OS)With impressive efficacy and a strong safety profile, this marks a solid step forward for CAR-T therapy in the field of solid tumors.
Research Methods:
This study is a single-arm, open-label Phase I clinical trial (NCT060006390) conducted in China, aiming to evaluate the safety and preliminary efficacy of C-13-X in advanced metastatic NSCLC.
Key inclusion criteria included: age ≥18 years, histologically confirmed stage IV NSCLC, failure of at least two prior lines of standard therapy, ECOG performance status score ≤2, and tumor cell CEA positivity rate ≥10%. All enrolled patients received standard lymphodepleting chemotherapy (fludarabine 25 mg/m², cyclophosphamide 300 mg/m² for 3 days) five days prior to CAR-T cell infusion.
The primary evaluation endpoints include safety, disease control rate (DCR), objective response rate (ORR), duration of response (DOR), and overall survival (OS).
Research Results:            
From August 2023 to December 2024, a total of 15 eligible advanced-stage patients received C-13-X infusions and were included in the analysis. These patients represent a highly refractory population: median age 60 years (range: 52-65 years), median number of prior treatment lines up to 4 (range: 3-6 lines), 53.3% (8/15) of patients had ≥3 organ metastases, 20% (3/15) had brain metastases, and 40% (6/15) had tumors with a diameter ≥5cm.
  • Excellent Survival Benefits and Disease Remission: As of the data cutoff date, the 1-year OS rate reached 71.1%; the overall DCR was as high as 87% (13/15), with the DCR for lung target lesions reaching 93%; ORR was 47% (7/15). Notably, patients with CEA expression levels ≥30% showed a better trend of remission.
  • Overall Tolerability was Good: CRS occurred in 93% (14/15) of patients, with low severity. Only one case of Grade 3 CRS was reported, and no cases of Grade 4 or higher CRS were observed. No ICANS of any grade was reported. Other major adverse reactions included cytopenia (e.g., anemia, leukopenia, neutropenia), rash (73%, 11/15), fever (93%, 14/15), and hypoproteinemia (93%, 14/15). Most resolved quickly after symptomatic treatment. No treatment-related deaths occurred.
  • Persistent in vivo expansion and persistence: C-13-X reached its peak concentration at a median of 10 days post-infusion, with 50763 copies/μg gDNA, and CAR copies were still detectable in patients with up to 13 months of follow-up.

Source: Precision Biotech

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