NCT07249879

This Study is an Open-lable, Phase I Study to Evaluate the Safety, Feasibility, Cytokinetics, and Preliminary Efficacy of GC511B in DLL3+ Relapsed/Refractory Small Cell Lung Cancer.

A Phase 1, First-in-Human, Investigator-Initiated, Open-label Study to Assess the Safety, Feasibility, Cytokinetics, and Preliminary Antitumor Activity of GC511B in Adult Subjects With DLL3+ Relapsed/Refractory Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a First-in-Human, open-label, phase I dose-escalation clinical study to evaluate the safety and preliminary efficacy of GC511B CAR T cell injection in Adult with DLL3+ r/r SCLC subjects.

Detailed description

This is a First-in-Human, open-label, phase I dose-escalation clinical study to evaluate the safety and preliminary efficacy of GC511B CAR T cell injection in Adult with DLL3+ r/r SCLC subjects. this study consists of two parts: dose escalation and dose expansion: Dose Escalation: This part consists of two stages:Stage 1: Accelerated titration design to explore the effective starting dose;Stage 2: Bayesian optimal interval (BOIN) design to explore the MAD/MTD.The BOIN design will start with aDL1 as determined in Stage 1 and continue until either 9 subjects have been enrolled at a single dose level (DL) or the total number of subjects reaches 11.During the dose-escalation phase, following each dose level (DL) and/or scheduled dosing time point, the Safety Review Committee (SRC) will evaluate all adverse events (AEs), serious adverse events (SAEs), laboratory safety data from subjects in the DLT observation period, as well as all other relevant available data, to determine the next DL to be explored and/or dosing schedule and to provide recommendations for subsequent study conduct. Dose expansion : The dose expansion phase will be initiated at the defined RDE to further investigate the safety, feasibility, CK, immunogenicity, PD, and preliminary antitumor activity of GC511B monotherapy and/or combination therapy. Up to 4 expansion cohorts may be opened to evaluate specific DLs and indications with up to 20 response-evaluable subjects included in each cohort.

Conditions

• Relapsed/Refractory Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	GC511B CAR-T Cell Injection	This product is a lentiviral gene-modified autologous chimeric antigen receptor T-cell product that GC511B.Administration of GC511B CAR T-Cells a dose levels of DL1,DL2,DL3 and DL4 are administrated for each subject.Single IV infusion.

Timeline

• Start date: 2025-11-21
• Primary completion: 2026-11-10
• Completion: 2028-12-10
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

2 sites across 1 country: China