Squamous Cell Lung CancerPhase 1NCT07444281
An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer
A Phase 1 study testing C-CAR031 in people with Squamous Cell Lung Cancer, run by Shanghai AbelZeta Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Cell Lung Cancer
- What is being tested?
- C-CAR031
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 30 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Ziming Li, MD, +86-21-62821990, liziming1980@hotmail.com
About this study
Official 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
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
- Being tested
- C-CAR031
- Keywords
- squamous cell lung cancer, advanced squamous cell lung cancer, metastatic squamous cell lung cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-CAR031Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| C-CAR031 Cohort 1 | Experimental | Dose Level 1 at 0.75mpk C-CAR031 to be infused to subjects Receives: Drug: C-CAR031 |
| C-CAR031 Cohort 2 | Experimental | Dose Level 2 at 1.5mpk C-CAR031 to be infused to subjects Receives: Drug: C-CAR031 |
| C-CAR031 Cohort 3 | Experimental | Dose Level 3 at 4.0mpk C-CAR031 to be infused to subjects Receives: Drug: C-CAR031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE/SAE/AESI, DLT
- To assess the safety and tolerability of C-CAR031 in participants
- To determine the RDE (Phase Ia)
Measured: From baseline to 28 days after treatment
Secondary outcomes (9)
ORR (Objective Response Rate)
To estimate the anti-tumor activity of C-CAR031 in participants with GPC3+ advanced/metastatic squamous cell lung cancer
Measured: From baseline until disease progression likely at 12 months
CK Parameter and Quantification of CAR copies/μg DNA of C-CAR031
To investigate the CK of C-CAR031
Measured: From baseline until 15 years of infusion as longest
Presence of RCL
To assess the safety of C-CAR031
Measured: From baseline until 15 years of infusion as longest
DCR (Disease Control Rate)
To estimate the anti-tumor activity of C-CAR031 in participants with GPC3+ advanced/metastatic squamous cell lung cancer
Measured: From baseline until disease progression likely at 12 months after treatment
DoR (Duration of Response)
Measured: From baseline until disease progression likely at 12 months after treatment
DRR (Durable Response Rate)
Measured: From baseline until disease progression likely at 12 months after treatment
TTR (Time to Response)
Measured: From baseline until disease progression likely at 12 months after treatment
PFS (Progression-free Survival)
Measured: From baseline until disease progression likely at 12 months after treatment
Change in tumor size
Measured: From baseline until disease progression likely at 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start25 Dec 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai AbelZeta Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, MD, Principal investigator, Shanghai Chest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444281
- Sponsor's protocol ID
- 0926-045
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07444281
- Acronym / sponsor ID
- 0926-045
- Conditions
- Squamous Cell Lung Cancer
- Keywords
- squamous cell lung cancer, advanced squamous cell lung cancer, metastatic squamous cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai AbelZeta Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C-CAR031 Cohort 1 | Experimental | Drug: C-CAR031Dose Level 1 at 0.75mpk C-CAR031 to be infused to subjects |
| C-CAR031 Cohort 2 | Experimental | Drug: C-CAR031Dose Level 2 at 1.5mpk C-CAR031 to be infused to subjects |
| C-CAR031 Cohort 3 | Experimental | Drug: C-CAR031Dose Level 3 at 4.0mpk C-CAR031 to be infused to subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-CAR031C-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). | Drug | C-CAR031 Cohort 1, C-CAR031 Cohort 2, C-CAR031 Cohort 3 |
Primary outcome
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)
9 secondary outcomes
ORR (Objective Response Rate)
Time frame: 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
Presence of RCL
Time frame: 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
DoR (Duration of Response)
Time frame: 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
TTR (Time to Response)
Time frame: 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
Change in tumor size
Time frame: From baseline until disease progression likely at 12 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shun Lu, MD principal investigator
Shanghai Chest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C-CAR031 in people with Squamous Cell Lung Cancer, run by Shanghai AbelZeta Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yinghua Shen (+86-18616644879, yinghua.shen@abelzeta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE/SAE/AESI, DLT (time frame: From baseline to 28 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.