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Tests treatment safety and results for Relapsed/Refractory Small Cell Lung Cancer
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.
ClinicalTrials.gov ID: NCT07249879
What this study is testing
What is GC511B CAR-T Cell Injection?
GC511B CAR-T Cell Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 1.Trial articipant must be ≥ 18 years and ≤75 years of age at the time of signing the ICF. Type of people 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...
You likely can't join if
- 1.Pregnant or breastfeeding females, or female trial participants with a positive pregnancy test result during the screening period (females not of...
- 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...
- 3.Trial participants has a history of other acquired or congenital immunodeficiency; trial participants received organ transplant or bone marrow...
- 4.The trial participants has a serious arterial/venous thromboembolic event or cerebrovascular accident within 6 months before apheresis, such as...
- 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...
See the full eligibility criteria
Who can join
- 1.Trial articipant must be ≥ 18 years and ≤75 years of age at the time of signing the ICF. Type of people 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;
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 treatment 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...
- 19.Trial participants with brain metastases and/or carcinomatous meningitis; people who previously received treatment for brain metastases may be considered if there is no evidence of disease progression confirmed by...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.