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 | Recruiting Phase 1 DMC

• 1 other identifier: N6762000000
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Relapsed/Refractory Small Cell Lung Cancer;; DLL3+ expression; CAR-T cell therapy

Outcome Measures

Primary Outcomes (7)

• Dose-Limiting Toxicity (DLT) Rate

  DLT is defined as an AE that occurs within 28 days of GC511B CAR-T product reinfusion.DLT will be evaluated according to NCI-CTCAE V5.0 criteria

  28 days

• Adverse Events （AEs）

  Proportion of trial participants experiencing AE within 15 years after infusion of GC511B CAR-T cell injection.

  Up to 15 years from treatment discontinuation

• Changes in vital signs to baseline

  Include body temperature by CTCAE V5.0

  Up to 24 months from treatment discontinuation

• Changes in Electrocardiogram(ECG) to baseline

  ECG QT intervals

  Up to 24 months from treatment discontinuation

• Changes in vital signs to baseline

  Systolic and diastolic blood pressure by CTCAE V5.0

  Up to 24 months from treatment discontinuation

• Changes in vital signs to baseline

  Respiratory rate by CTCAE V5.0

  Up to 24 months from treatment discontinuation

• Changes in vital signs to baseline

  Pulse by CTCAE V5.0

  Up to 24 months from treatment discontinuation

Secondary Outcomes (14)

• Area under the concentration time curve (AUC)

  Up to 15 years from treatment discontinuation

• Maximum plasma concentration (Cmax)

  Up to 15 years from treatment discontinuation

• Time to maximum plasma concentration (Tmax)

  Up to 15 years from treatment discontinuation

• Last detectable time point（Tlast）

  Up to 15 years from treatment discontinuation

• Last quantifiable concentratione (Clast)

  Up to 15 years from treatment discontinuation

Study Arms (1)

GC511B CAR-T Cell Injection

EXPERIMENTAL

This study is a open-label clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of GC511B dual CAR-T injection in Relapsed/Refractory Small Cell Lung Cancer trial participants . The enrolled trial participants were patients with DLL3+ Relapsed/Refractory Small Cell Lung Cancer (r/r SCLC) .

Drug: GC511B CAR-T Cell Injection

Interventions

GC511B CAR-T Cell Injection DRUG

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.

GC511B CAR-T Cell Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trial articipant must be ≥ 18 years and ≤75 years of age at the time of signing the ICF.
• Type of Subjects and Disease Characteristics
• ECOG performance status 0-2.
• Life expectancy ≥ 12 weeks.
• At least 1 TL meeting RECIST v1.1 at screening. Tumor assessment by CT scan or MRI must be performed within 28 days prior to apheresis.
• A lesion can be considered TL if the lesion previously subjected to radiotherapy has a clear boundary, is measurable as per RECIST v1.1, and has clear progression during or after the latest treatment;
• If a fresh biopsy sample is selected at screening from a tumor lesion, the tumor lesion should not be selected as a TL unless imaging is performed at least approximately 2 weeks after the biopsy to allow time for healing. In a case where there is only one measurable TL, caution should be taken when obtaining biopsy tissues during the treatment period.
• Archival or freshly biopsied tumor tissue for assessment of DLL3 expression levels can be provided.
• Adequate organ function:
• a.Blood function: i.Hemoglobin ≥ 9 g/dL (without transfusion or erythropoietin therapy within 2 weeks prior to screening assessment); ii.Absolute neutrophil count ≥ 1.5×10\^9/L and absolute lymphocyte count ≥ 0.6×10\^9/L (without G-CSF use within 2 weeks prior to screening assessment);iii.Platelet count ≥ 75×10\^9/L (without platelet transfusion or recombinant human thrombopoietin within 2 weeks prior to screening assessment).
• b.Hepatic function (based on normal values as defined by the clinical study site):i.Serum TBL ≤ 1.5 ×ULN;ii.ALT or AST ≤ 2.5×ULN in the absence of liver metastases; ALT and AST ≤ 5×ULN in the presence of liver metastases.
• c.Renal function (based on normal values as defined by the clinical study site): i.Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/minute calculated using the Cockcroft-Gault formula, or creatinine clearance ≥ 60 mL/minute calculated using 24-hour urine.ii.Urine protein \<++. For trial participants with proteinuria ≥ ++ on urine test paper at baseline, 24-hour urine must be collected and the content of protein in urine within 24 hours must be \< 1 g.
• d.Coagulation function (based on normal values as defined by the clinical study site):i.PT≤1.5×ULN；ii.Thrombin time ≤ 1.5×ULN;iii.aPTT≤1.5×ULN。
• e.Cardiac function:i.New York Heart Association classification \< class 3;ii.LVEF ≥ 50%.
• Able to establish venous access and, in the judgment of the investigator, suitable for PBMC collection.

You may not qualify if:

• Pregnant or breastfeeding females, or female trial participants with a positive pregnancy test result during the screening period (females not of childbearing potential are not required to receive a pregnancy test, such as metrectomy and/or bilateral oophorectomy, or amenorrhea for ≥ 12 months).
• \. Trial participants who have received a live vaccine within 4 weeks prior to initiation of apheresis or who plan to receive any vaccine (other than coronavirus disease 2019 vaccine) during the study.
• Trial participants has a history of other acquired or congenital immunodeficiency; trial participants received organ transplant or bone marrow transplant.
• The trial participants has a serious arterial/venous thromboembolic event or cerebrovascular accident within 6 months before apheresis, such as deep venous thrombosis (excluding asymptomatic and untreated muscle venous thrombosis), pulmonary embolism, cerebral infarction, cerebral hemorrhage and except for myocardial infarction that is asymptomatic and does not require clinical intervention.
• The trial participant has hereditary or acquired haemorrhage and thrombophilia (e.g., hemophilia, coagulation disorder, splenomegaly);
• The trial participant has a QTc interval \> 450 ms (males) or \> 470 ms (females) during the screening period; the trial participant has a family or personal history of long or short QT syndrome;The trial participants had a history of unstable angina pectoris, severe arrhythmia, severe non-ischemic cardiomyopathy, or had undergone myocardial infarction or cardiovascular surgery within 6 months.
• The trial participant has other diseases that may seriously endanger the safety of the trial participant or affect the completion of the study, such as peptic ulcer, intestinal obstruction, intestinal paralysis, pulmonary fibrosis, renal failure, and uncontrolled diabetes.
• The trial participants has an active or ongoing infection requiring systemic intravenous treatment (the trial participant may start study treatment 2 weeks after completion of anti-infective therapy).
• History of any autoimmune nervous system disorder, including but not limited to: multiple sclerosis, neuromyelitis optica spectrum disorder, myasthenia gravis, Guillain Barre syndrome, and chronic inflammatory demyelinating polyradiculoneuropathy. Other active autoimmune or inflammatory disorders, including but not limited to inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, granulomatosis with polyangiitis, autoimmune thyroid disease (Graves' disease) or rheumatoid arthritis. The following are exceptions to this criterion:
• The trial participant has vitiligo or autoimmune alopecia;
• The trial participant has autoimmune hypothyroidism (e.g., following Hashimoto's thyroiditis) and is stable on hormone replacement;
• Any chronic inflammatory or autoimmune skin disease that does not require systemic therapy;
• Trial participants without active disease in the past 5 years may be enrolled in the study, but must first consult with the investigator;
• Trial participants whose celiac disease is controlled by dietary management alone.
• \. Trial participants with known life-threatening hypersensitivity or other intolerance to cyclophosphamide or fludarabine, or severe allergic constitution; trial participants with allergy to human serum albumin and dimethyl sulfoxide.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Gracell Biotechnologies (Shanghai) Co., Ltd.: collaborator

Study Sites (2)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Gobroad Hospital

Beijing, Beijing Municipality, 102206, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ning Li, Ph.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, Ph.D.

CONTACT

+86 15601395554; lining@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Professor

Model Details: The study will be conducted in two stages: Dose escalation stage: To determine MTD/MAD and evaluate the safety and tolerability of GC511B monotherapy. Dose expansion stage: To further determine RDE and evaluate the preliminary efficacy of GC511B monotherapy.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 25, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): December 10, 2028
• Last Updated: May 1, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)