Actively Recruiting
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.
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-05-01
55
Participants Needed
2
Research Sites
144 weeks
Total Duration
On this page
Sponsors
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead Sponsor
G
Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at the time of informed consent
- ECOG performance status of 0 to 2
- Life expectancy of at least 12 weeks
- At least one measurable tumor lesion according to RECIST v1.1 within 28 days prior to apheresis
- Ability to provide archival or fresh tumor tissue for DLL3 expression assessment
- Adequate organ function including specified blood counts, liver, kidney, coagulation, and cardiac function
- Suitable venous access for PBMC collection
- Women of childbearing potential must be non-lactating and have a negative pregnancy test during screening
- Agreement to use effective contraception during treatment and for 2 years after last CAR-T infusion or until negative CAR test
- Agreement not to donate sperm or eggs during treatment and for 2 years after last CAR-T infusion or until negative CAR test
- Ability to provide informed consent and comply with study requirements
- Willingness and ability to complete the study as required
You will not qualify if you...
- Pregnant or breastfeeding women, or women with positive pregnancy test during screening
- Receipt of live vaccine within 4 weeks prior to apheresis or planned vaccination (other than COVID-19 vaccine) during the study
- History of congenital or acquired immunodeficiency or prior organ/bone marrow transplant
- Recent serious thromboembolic events or cerebrovascular accidents within 6 months prior to apheresis
- Hereditary or acquired bleeding or clotting disorders
- QTc interval >450 ms (male) or >470 ms (female), or history of serious heart conditions
- Serious diseases that may endanger safety or study completion, such as peptic ulcer, intestinal obstruction, pulmonary fibrosis, renal failure, or uncontrolled diabetes
- Active infections requiring intravenous treatment
- History of autoimmune nervous system disorders or active autoimmune/inflammatory diseases except specified stable conditions
- Known severe allergies or hypersensitivities to study drugs or components
- Active or chronic infections including hepatitis B, C, HIV, or syphilis
- Prior CAR-T or gene-editing therapy, recent participation in other clinical studies, or recent systemic corticosteroid or anticancer therapies as specified
- Unrecovered toxicities from previous anticancer treatments
- Recent major surgeries not fully recovered
- Evidence of interstitial lung disease or active pneumonitis
- Transformed SCLC or symptomatic effusions requiring drainage
- Brain metastases or carcinomatous meningitis, except stable treated brain metastases
- Other malignancies within 5 years except certain treated cancers
- Any other conditions deemed unsuitable by investigator
- Inadequate study compliance
- History or current diagnosis of uncontrolled psychosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Beijing Gobroad Hospital
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
Research Team
N
Ning Li, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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