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| Name | Class |
|---|---|
| Shanghai Chest Hospital | OTHER |
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This study is a FIH dose escalation clinical study, with single arm, open label and design, in order to observe the preliminary safety and Pharmacokinetic of SNC115 Injection in participants with Recurrent/refractory small cell lung cancer and Lung large cell neuroendocrine carcinoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNC115 injection | Drug | SNC115 Injection is DLL3 CART. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of SNC115 Injection | Safety of SNC115 Injection will be assessed by incidence and severity of AEs and SAEs. | Day 1 through Month 18 |
| Safety of SNC115 Injection | Safety of SNC115 Injection will be assessed by occurrenced rate of DLT. | Day 1 through Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| -Efficacy of SNC115 Injection | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| -PK characteristic of SNC115 Injection. | PK parameters will include Cmax . | Day 1 through Month 18 |
| -PK characteristic of SNC115 Injection. | PK parameters will include Tmax. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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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 | 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 | 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 | 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 | Efficacy of SNC115 will be characterized by TTR,according to investigator assessment referring RECISIT 1.1. | Day 1 through Month 18 |
| Day 1 through Month 18 |
| PK characteristic of SNC115 Injection. | PK parameters will include AUC0-28d. | Day 1 through Month 18 |
| PK characteristic of SNC115 Injection. | PK parameters will include AUC0-last. | Day 1 through Month 18 |
| PK characteristic of SNC115 Injection. | PK parameters will include Clast. | Day 1 through Month 18 |
| PK characteristic of SNC115 Injection. | PK parameters will include Tlast . | Day 1 through Month 18 |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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