An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer

February 27, 2026 updated by: Shanghai AbelZeta Ltd.

An Investigator-initiated Phase I Trial of an Armored and GPC3-targeted Autologous CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer

This single-arm, open-label, multicenter, Phase I study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK)/pharmacodynamics (PD), biomarker, and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced/metastatic squamous cell lung cancer, who are not amenable to curative therapy and have progressed or are intolerant to no more than 3 lines of prior systemic treatment including immune checkpoint inhibitors (CPIs) and platinum-based doublet chemotherapy, concurrently or sequentially.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed unresectable Stage IIIB ,IIIC or IV squamous cell lung cancer
  • Confirmed to express GPC3, as assessed by immunohistochemistry at a central lab
  • Participants who have progressed or intolerant to no more than three lines of prior systemic therapies for advanced/metastatic squamous cell lung cancer
  • At least one measurable target lesion
  • The left ventricular ejection fraction (LVEF) measured by echocardiography ≥50% and reported as non-impaired.
  • Sufficient pulmonary function
  • The laboratory testing results meet the study requirements
  • Female participants of childbearing potential must test negative for pregnancy in serum or urine. Non-sterilized participants (males and females) agree to take effective contraceptive measures for at least 12 months and until CAR-T below lower limit of detection (LLOD) by PCR which occurs last after C-CAR031 infusion.

Exclusion Criteria:

  • known to harbor a driver mutation for which targeted standard therapy is recommended in accordance with local treatment guidelines.
  • Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO)
  • Contraindication to lymphodepleting agents, including fludarabine and/or cyclophosphamide.
  • History of splenectomy or organ transplantation
  • Prior treatment with Any CAR-T therapy OR any therapy that is targeting GPC3
  • Uncontrolled or intercurrent pulmonary disease
  • Clinically meaningful ascites
  • Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures
  • Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases
  • Received radiation therapy, local treatment, vaccine, blood transfusion, systemic treatment within certain period of apheresis required by study protocol
  • History of or with active diseases or conditions of that's defined in study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C-CAR031 Cohort 1
Dose Level 1 at 0.75mpk C-CAR031 to be infused to subjects
Drug: C-CAR031
C-CAR031 is an autologous CAR T-cell product that expresses a CAR specific for GPC3 and a dominant-negative transforming growth factor-beta receptor II (dnTGFβRII).
Experimental: C-CAR031 Cohort 2
Dose Level 2 at 1.5mpk C-CAR031 to be infused to subjects
Drug: C-CAR031
C-CAR031 is an autologous CAR T-cell product that expresses a CAR specific for GPC3 and a dominant-negative transforming growth factor-beta receptor II (dnTGFβRII).
Experimental: C-CAR031 Cohort 3
Dose Level 3 at 4.0mpk C-CAR031 to be infused to subjects
Drug: C-CAR031
C-CAR031 is an autologous CAR T-cell product that expresses a CAR specific for GPC3 and a dominant-negative transforming growth factor-beta receptor II (dnTGFβRII).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE/SAE/AESI, DLT
Time Frame: From baseline to 28 days after treatment
  • To assess the safety and tolerability of C-CAR031 in participants
  • To determine the RDE (Phase Ia)
From baseline to 28 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR (Objective Response Rate)
Time Frame: From baseline until disease progression likely at 12 months
To estimate the anti-tumor activity of C-CAR031 in participants with GPC3+ advanced/metastatic squamous cell lung cancer
From baseline until disease progression likely at 12 months
CK Parameter and Quantification of CAR copies/μg DNA of C-CAR031
Time Frame: From baseline until 15 years of infusion as longest
To investigate the CK of C-CAR031
From baseline until 15 years of infusion as longest
Presence of RCL
Time Frame: From baseline until 15 years of infusion as longest
To assess the safety of C-CAR031
From baseline until 15 years of infusion as longest
DCR (Disease Control Rate)
Time Frame: From baseline until disease progression likely at 12 months after treatment
To estimate the anti-tumor activity of C-CAR031 in participants with GPC3+ advanced/metastatic squamous cell lung cancer
From baseline until disease progression likely at 12 months after treatment
DoR (Duration of Response)
Time Frame: From baseline until disease progression likely at 12 months after treatment
From baseline until disease progression likely at 12 months after treatment
DRR (Durable Response Rate)
Time Frame: From baseline until disease progression likely at 12 months after treatment
From baseline until disease progression likely at 12 months after treatment
TTR (Time to Response)
Time Frame: From baseline until disease progression likely at 12 months after treatment
From baseline until disease progression likely at 12 months after treatment
PFS (Progression-free Survival)
Time Frame: From baseline until disease progression likely at 12 months after treatment
From baseline until disease progression likely at 12 months after treatment
Change in tumor size
Time Frame: From baseline until disease progression likely at 12 months after treatment
From baseline until disease progression likely at 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai AbelZeta Ltd.

Investigators

  • Principal Investigator: Shun Lu, MD, Shanghai Chest Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

January 30, 2028

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0926-045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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