- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06384482
SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma
To Evaluate the Safety and Pharmacokinetic of SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Crcinoma: an Open-label, Single-arm, Dose Escalation Exploratory Study
Study Overview
Status
Intervention / Treatment
Detailed Description
The study will enroll at most 35 participants diagnosed with Recurrent/refractory small cell lung cancer or Lung large cell neuroendocrine carcinoma.
There will be about 5 preset dose groups in this clinical trial, Participants will be enrolled from low dose group to high dose group. Dose escalation will be decided by the SRC (Safety Review Committee). There will be expanded cases in the aim dose group.
The protocol will be performed into Screening period (-30+ days), Mononuclear cells acquisition, Lymphodepletion (-5~-3 days), SNC115 Injection infusion and DLT observation period (day 0~28days), and follow-up period (1-5 years). According to the administration strategy, we will start from single administration.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200030
- Recruiting
- Shanghai Chest Hospital
-
Contact:
- Hua Zhong, MD/PhD
- Phone Number: 021-22200000
- Email: ctqxkyy@163.com; eddiedong8@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years old, regardless of gender;
- Histological or cytological diagnosis of SCLC or pulmonary LCNEC (WHO 2021)
- Relapse or refractory after receiving at least first-line standard therapy, or inability to tolerate first-line standard therapy
- Eastern Cooperative Oncology Group score 0-1;
- At least one measurable tumor lesion (other than brain metastases) according to solid tumor response criteria 1.1 (RECIST1.1)
- Measurable lesions with an expected survival of more than 3 months;
- Expected survival ≥12 weeks.
- Adequate organ and bone marrow function.
- The subjects agreed to use reliable contraceptive methods for contraception within 1 year from the signing of informed consent to reinfusion.
- Voluntarily participate in clinical trials and sign informed consent.
Exclusion Criteria:
- Known allergic reaction, hypersensitivity, intolerance or contraindication to SNC115 Injection or any component of drugs that may be used in the study (including fludarabine, cyclophosphamide and Tocilizumab).
- Have received any previous CAR-T therapy or other gene-modified cell therapy.
- Have received any previous treatment targeting DLL3.
- Uncontrolled pleural effusion, pericardial effusion, and ascites (uncontrolled refers to repeated drainage).
- Untreated (including new lesions or progression after previous treatment) or symptomatic brain metastases.
- Have medical history of study excluded thrombosis, Systemic autoimmune disease, cardiopathy, cancer, infection disease and so on.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
|
SNC115 Injection is DLL3 CART.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of SNC115 Injection
Time Frame: Day 1 through Month 18
|
Safety of SNC115 Injection will be assessed by incidence and severity of AEs and SAEs.
|
Day 1 through Month 18
|
Safety of SNC115 Injection
Time Frame: Day 1 through Month 18
|
Safety of SNC115 Injection will be assessed by occurrenced rate of DLT.
|
Day 1 through Month 18
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
-Efficacy of SNC115 Injection
Time Frame: Day 1 through Month 18
|
Efficacy of SNC115 will be characterized by ORR,according to investigator assessment referring RECISIT 1.1.
|
Day 1 through Month 18
|
-Efficacy of SNC115 Injection
Time Frame: Day 1 through Month 18
|
Efficacy of SNC115 will be characterized by DoR,according to investigator assessment referring RECISIT 1.1.
|
Day 1 through Month 18
|
-Efficacy of SNC115 Injection
Time Frame: Day 1 through Month 18
|
Efficacy of SNC115 will be characterized by DCR,according to investigator assessment referring RECISIT 1.1.
|
Day 1 through Month 18
|
-Efficacy of SNC115 Injection
Time Frame: Day 1 through Month 18
|
Efficacy of SNC115 will be characterized by PFS,according to investigator assessment referring RECISIT 1.1.
|
Day 1 through Month 18
|
-Efficacy of SNC115 Injection
Time Frame: Day 1 through Month 18
|
Efficacy of SNC115 will be characterized by OS,according to investigator assessment referring RECISIT 1.1.
|
Day 1 through Month 18
|
-Efficacy of SNC115 Injection
Time Frame: Day 1 through Month 18
|
Efficacy of SNC115 will be characterized by TTR,according to investigator assessment referring RECISIT 1.1.
|
Day 1 through Month 18
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
-PK characteristic of SNC115 Injection.
Time Frame: Day 1 through Month 18
|
PK parameters will include Cmax .
|
Day 1 through Month 18
|
-PK characteristic of SNC115 Injection.
Time Frame: Day 1 through Month 18
|
PK parameters will include Tmax.
|
Day 1 through Month 18
|
PK characteristic of SNC115 Injection.
Time Frame: Day 1 through Month 18
|
PK parameters will include AUC0-28d.
|
Day 1 through Month 18
|
PK characteristic of SNC115 Injection.
Time Frame: Day 1 through Month 18
|
PK parameters will include AUC0-last.
|
Day 1 through Month 18
|
PK characteristic of SNC115 Injection.
Time Frame: Day 1 through Month 18
|
PK parameters will include Clast.
|
Day 1 through Month 18
|
PK characteristic of SNC115 Injection.
Time Frame: Day 1 through Month 18
|
PK parameters will include Tlast .
|
Day 1 through Month 18
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Lung Neoplasms
- Carcinoma
- Recurrence
- Small Cell Lung Carcinoma
- Carcinoma, Neuroendocrine
Other Study ID Numbers
- SNC115-DLL3 CART-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma
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National Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung CancerUnited States
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