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

NCT07444281 | Recruiting Phase 1

• 1 other identifier: 0926-045
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Squamous Cell Lung Cancer

Keywords

squamous cell lung cancer; advanced squamous cell lung cancer; metastatic squamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• AE/SAE/AESI, DLT

  * 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 Outcomes (9)

• ORR (Objective Response Rate)

  From baseline until disease progression likely at 12 months

• CK Parameter and Quantification of CAR copies/μg DNA of C-CAR031

  From baseline until 15 years of infusion as longest

• Presence of RCL

  From baseline until 15 years of infusion as longest

• DCR (Disease Control Rate)

  From baseline until disease progression likely at 12 months after treatment

• DoR (Duration of Response)

  From baseline until disease progression likely at 12 months after treatment

Study Arms (3)

C-CAR031 Cohort 1

EXPERIMENTAL

Dose Level 1 at 0.75mpk C-CAR031 to be infused to subjects

Drug: C-CAR031

C-CAR031 Cohort 2

EXPERIMENTAL

Dose Level 2 at 1.5mpk C-CAR031 to be infused to subjects

Drug: C-CAR031

C-CAR031 Cohort 3

EXPERIMENTAL

Dose Level 3 at 4.0mpk C-CAR031 to be infused to subjects

Drug: C-CAR031

Interventions

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).

C-CAR031 Cohort 1; C-CAR031 Cohort 2; C-CAR031 Cohort 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

• Shun Lu, MD

  Shanghai Chest Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinghua Shen

CONTACT

+86-18616644879; yinghua.shen@abelzeta.com

Study Design

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

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: March 2, 2026
• Study Start: December 25, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)