This Study is an Open-lable, Early Study to Evaluate the Safety, Feasibility, Cytokinetics, and Preliminary Efficacy of GC511B in DLL3+ Relapsed/Refractory Small Cell Lung Cancer.
NCT07249879 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2026-05-01
Summary
This is a First-in-Human, open-label, early dose-escalation clinical study to evaluate the safety and preliminary efficacy of GC511B CAR T cell injection in Adult with DLL3+ r/r SCLC trial participants.
Conditions
- Relapsed/Refractory Small Cell Lung Cancer
Interventions
- 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 trial participants.Single IV infusion.
Sponsors & Collaborators
-
Gracell Biotechnologies (Shanghai) Co., Ltd.
collaborator INDUSTRY -
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
lead OTHER
Principal Investigators
-
Ning Li, Ph.D. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-03
- Primary Completion
- 2026-11-10
- Completion
- 2028-12-10
Countries
- China
Study Locations
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