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

ConditionSquamous Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai AbelZeta Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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).

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: C-CAR031 Cohort 1Experimental treatment 1 intervention
Group B: C-CAR031 Cohort 2Experimental treatment 1 intervention
Group C: C-CAR031 Cohort 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AE/SAE/AESI, DLT

* To assess the safety and tolerability of C-CAR031 in participants * To determine the RDE (Phase Ia)

Time frame
From baseline to 28 days after treatment

Secondary outcomes

1

ORR (Objective Response Rate)

To estimate the anti-tumor activity of C-CAR031 in participants with GPC3+ advanced/metastatic squamous cell lung cancer

Time frame
From baseline until disease progression likely at 12 months
2

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

To investigate the CK of C-CAR031

Time frame
From baseline until 15 years of infusion as longest
3

Presence of RCL

To assess the safety of C-CAR031

Time frame
From baseline until 15 years of infusion as longest
4

DCR (Disease Control Rate)

To estimate the anti-tumor activity of C-CAR031 in participants with GPC3+ advanced/metastatic squamous cell lung cancer

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai AbelZeta Ltd.

Lead sponsor

Source ClinicalTrials.gov
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