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Relapsed/Refractory Small Cell Lung CancerPhase 1NCT07249879

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.

A Phase 1 study testing GC511B CAR-T Cell Injection in people with Relapsed/Refractory Small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
GC511B CAR-T Cell Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesChina
Study dates
3 Mar 2026to 10 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1.Trial articipant must be ≥ 18 years and ≤75 years of age at the time of signing the ICF.
  • Type of Subjects and Disease Characteristics
  • 2.ECOG performance status 0-2.
  • 3.Life expectancy ≥ 12 weeks.
  • 4.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;
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  • 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.
  • 5.Archival or freshly biopsied tumor tissue for assessment of DLL3 expression levels can be provided.
  • 6.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%.
  • 7.Able to establish venous access and, in the judgment of the investigator, suitable for PBMC collection.
  • 8.Women of childbearing potential must be non-lactating, and women of childbearing potential must have a negative result of highly sensitive serum pregnancy test during screening.
  • 9.All trial participants of childbearing age (including women of childbearing age and males with partners) must agree to take medically acceptable effective contraception measures as mentioned in Appendix F throughout the treatment period and for 2 years after the last CAR-T product reinfusion or until a negative CAR copy test, whichever occurs later.
  • 10.Male trial participants must agree not to donate sperm and female trial participants must agree not to donate eggs throughout the treatment period and for 2 years after the last CAR-T product reinfusion or until a negative CAR copy test, whichever occurs later.
  • 11.Capable of signing ICF (as mentioned in Appendix A), which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
  • 12.The trial participant has provided ICF before starting any study-specific activity/procedure.
  • 13.Able to communicate well with the investigator, and willing to comply with the study plan and able to complete the study as required.

Who cannot join

  • 1.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).
  • 2. 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.
  • 3.Trial participants has a history of other acquired or congenital immunodeficiency; trial participants received organ transplant or bone marrow transplant.
  • 4.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.
  • 5.The trial participant has hereditary or acquired haemorrhage and thrombophilia (e.g., hemophilia, coagulation disorder, splenomegaly);
  • 6.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.
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  • 7.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.
  • 8.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).
  • 9.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.
  • 10. 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.
  • 11.Active or chronic infectious diseases, including:
  • HBV infection, defined as HBsAg positive or hepatitis B core antibody positive and HBV-DNA detectable;
  • HCV infection, defined as HCV antibody positive and HCV-RNA detectable;
  • HIV infection, defined as anti-HIV (1/2) positive;
  • Syphilis infection, defined as TPPA positive with clinical or exposure evidence.
  • 12.Prior receipt of anti-tumor therapies or participation in clinical studies;
  • The trial participant has received prior CAR-T cell therapy or other gene-editing cell therapy;
  • The trial participant participated in other clinical studies within 28 days prior to screening;
  • Use of systemic corticosteroids (excluding inhaled corticosteroids) at a daily dose of ≥ 10 mg within 7 days prior to apheresis;
  • Use of chemotherapy, immunotherapy, or targeted therapy within 4 weeks or less than 5 drug half-lives, whichever is shorter, prior to apheresis;
  • Having received radical radiotherapy or radiotherapy with a bone marrow proportion greater than 30% at the radiotherapy site or whole brain radiotherapy within 4 weeks before apheresis, and having received local palliative radiotherapy aimed at alleviating symptoms within 2 weeks before apheresis;
  • Trial participants who have received traditional Chinese medicine treatment for a clear anti-tumor indication within 2 weeks before apheresis.
  • 13.Toxicities from prior anticancer therapy that have not recovered to National Cancer Institute CTCAE v5.0 Grade 0 or Grade 1 (excluding alopecia, pigmentation, and other Grade ≤ 2 long-term toxicities considered irreversible by the investigator).
  • 14.Trial participants who previously discontinued administration due to adverse reactions such as immune-related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis.
  • 15.Trial participants who have undergone major surgical or interventional procedures within 4 weeks prior to apheresis and have not fully recovered (excluding tumor biopsy or paracentesis).
  • 16.Evidence of interstitial lung disease or active pneumonitis. Cancer-related
  • 17.Trial participants with transformed SCLC.
  • 18.Trial participants with pleural effusion, ascites, or pericardial effusion that is symptomatic or requires drainage (Note: Trial participants with effusions not requiring drainage within 1 week prior to enrollment or who have stopped drainage without significant increase in effusions may participate in this study).
  • 19.Trial participants with brain metastases and/or carcinomatous meningitis; subjects who previously received treatment for brain metastases may be considered if there is no evidence of disease progression confirmed by imaging within 28 days prior to apheresis, all neurological symptoms have recovered to baseline, and no radiotherapy, surgery, or steroid treatment has been received within 28 days prior to apheresis; Trial participants with carcinomatous meningitis should be excluded, whether clinically stable or not.
  • 20.Trial participants with other malignancy within 5 years prior to apheresis, with the exception of malignancy expected to be cured with treatment (including, but not limited to, adequately treated thyroid cancer, in situ cancer of cervix, basal or squamous cell carcinoma of skin, or ductal carcinoma in situ of the breast treated by radical operation).
  • 21.Trial participants have any other disease, metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the opinion of the investigator, suggests a condition or disease that would not be suitable for study treatment and may affect the interpretation of the study results or put the trial participants at high risk.
  • 22.Trial participants have inadequate compliance with the study in the opinion of the investigator or have other factors that would make the trial participants inappropriate for participation in the study.
  • 23.Trial participants with a history or current diagnosis of uncontrolled psychosis.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ning Li, Ph.D. contact

+86 15601395554

lining@cicams.ac.cn

China2 sites, 2 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Li Ning, Ph.D., +86 15601395554, lining@cicams.ac.cn

    Recruiting

  • Beijing Gobroad Hospital

    Beijing, Beijing Municipality, 102206

    Haifeng Qin, Ph.D., +8613601365243, hifo@263.net

    Recruiting

Other trials in China

About this study

Official title: An Early, First-in-Human, Investigator-Initiated, Open-label Study to Assess the Safety, Feasibility, Cytokinetics, and Preliminary Antitumor Activity of GC511B in Adult Trial Participants With DLL3+ Relapsed/Refractory Small Cell Lung Cancer

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.

Read the detailed description

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.

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 trial participants have been enrolled at a single dose level (DL) or the total number of trial participants reaches 11.Starting with BOIN stage DL3, the first and second trial participants were reinfused at least 2 weeks apart.During the dose-escalation phase, following each dose level (DL) and/or scheduled infusion 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 trial participants included in each cohort.

Being tested
GC511B CAR-T Cell Injection
Keywords
Relapsed/Refractory Small Cell Lung Cancer;, DLL3+ expression, CAR-T cell therapy
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GC511B CAR-T Cell InjectionDrug

    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.

Study groups in NCT07249879
Study groupRoleWhat they receive
GC511B CAR-T Cell InjectionExperimentalThis 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) .
Receives: Drug: GC511B CAR-T Cell Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 28 days

  2. Adverse Events （AEs）

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

    Measured: Up to 15 years from treatment discontinuation

  3. Changes in vital signs to baseline

    Include body temperature by CTCAE V5.0

    Measured: Up to 24 months from treatment discontinuation

  4. Changes in Electrocardiogram(ECG) to baseline

    ECG QT intervals

    Measured: Up to 24 months from treatment discontinuation

  5. Changes in vital signs to baseline

    Systolic and diastolic blood pressure by CTCAE V5.0

    Measured: Up to 24 months from treatment discontinuation

  6. Changes in vital signs to baseline

    Respiratory rate by CTCAE V5.0

    Measured: Up to 24 months from treatment discontinuation

  7. Changes in vital signs to baseline

    Pulse by CTCAE V5.0

    Measured: Up to 24 months from treatment discontinuation

Secondary outcomes (14)

  1. Area under the concentration time curve (AUC)

    Cytokinetics (CK) profile of GC511B CAR-T celltherapy

    Measured: Up to 15 years from treatment discontinuation

  2. Maximum plasma concentration (Cmax)

    Cytokinetics (CK) profile of GC511B CAR-T celltherapy

    Measured: Up to 15 years from treatment discontinuation

  3. Time to maximum plasma concentration (Tmax)

    Cytokinetics (CK) profile of GC511B CAR-T celltherapy

    Measured: Up to 15 years from treatment discontinuation

  4. Last detectable time point（Tlast）

    Cytokinetics (CK) profile of GC511B CAR-T celltherapy

    Measured: Up to 15 years from treatment discontinuation

  5. Last quantifiable concentratione (Clast)

    Cytokinetics (CK) profile of GC511B CAR-T celltherapy

    Measured: Up to 15 years from treatment discontinuation

  6. Replication-competent lentivirus(RCL) in peripheral blood

    RCL is monitored through mandatory viral testing

    Measured: At baseline and within the selected time after the infusion of GC511B CAR-T cell

  7. Objective Response Rate (ORR)

    ORR is defined as the percentage of subjects with confirmed CR or PR, and the denominator is defined as the number of subjects in the response evaluable set

    Measured: Up to 15 years study discontinuation

  8. Best Overall Response (BOR)

    BOR is defined as the best response a subject achieves based on evaluable data collected at all available time points prior to progression, or the last evaluable assessment result in the absence of disease progression or the initiation of subsequent anti-tumor therapy.

    Measured: Up to 15 years study discontinuation

  9. Duration of Response (DoR)

    DoR is defined as the time from the date of the first documented objective response (subsequently confirmed) to the first documented disease progression or death (for any reason in the absence of disease progression).

    Measured: Up to 15 years study discontinuation

  10. Disease Control Rate(DCR)

    DCR is defined as the percentage of trial participants who achieve and maintain a CR or PR after receiving CAR-T therapy, or who achieve SD and maintain that response.for at least 7 weeks

    Measured: 7Weeks

  11. Time to First Response（TTR）

    TTR is defined as the time from the date of CAR-T product reinfusion to the date of the first documented confirmed objective response that is subsequently confirmed

    Measured: Up to 15 years study discontinuation

  12. Percentage Change in Tumor Size

    Depth of tumor response is defined as the maximum percentage of shrinkage of TL compared with baseline.

    Measured: Up to 15 years study discontinuation

  13. Progression-free Survival(PFS)

    PFS is defined as the time from the date of CAR-T product reinfusion to the date of objective disease progression or death (all-cause death in the absence of progression).

    Measured: Up to 15 years study discontinuation

  14. Overall Survival(OS)

    OS is defined as the time from the date of CAR-T product reinfusion to the date of all-cause death, regardless of whether the subject receives another anti-tumor therapy.

    Measured: Up to 15 years study discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start3 Mar 2026
  3. Primary completion10 Nov 2026 (estimated)
  4. Study completion10 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07249879
Sponsor's protocol ID
N6762000000
Status last verified
Apr 2025
First submitted
13 Nov 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GC511B CAR-T Cell Injection in people with Relapsed/Refractory Small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ning Li, Ph.D. (+86 15601395554, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) Rate (time frame: 28 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07249879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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