An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer
Recruiting
Phase 1
Interventional Study
Squamous Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Shanghai AbelZeta Ltd. · Industry
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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 syst…
Trial Locations
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Eligibility Criteria
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 syste…
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