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NCT Number: NCT07444281

An Phase I Trial of a 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.

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Key information

Conditions

Squamous Cell Lung Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Ziming Li, MD

CONTACT

[email protected]

+86-21-62821990

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C-CAR031

Drug

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).

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. Presence of RCL

    Time frame: From baseline until 15 years of infusion as longest

    To assess the safety of C-CAR031

  4. 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

  5. DoR (Duration of Response)

    Time frame: From baseline until disease progression likely at 12 months after treatment

  6. DRR (Durable Response Rate)

    Time frame: From baseline until disease progression likely at 12 months after treatment

  7. TTR (Time to Response)

    Time frame: From baseline until disease progression likely at 12 months after treatment

  8. PFS (Progression-free Survival)

    Time frame: From baseline until disease progression likely at 12 months after treatment

  9. Change in tumor size

    Time frame: From baseline until disease progression likely at 12 months after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Yinghua Shen

CONTACT

[email protected]

+86-18616644879

Sponsors and collaborators

Lead sponsor

Shanghai AbelZeta Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 2, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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