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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma
• Intervention / Treatment: Drug: SNC115 injection

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: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • 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: No

Description

Inclusion Criteria:

1. Age ≥ 18 years old, regardless of gender;
2. Histological or cytological diagnosis of SCLC or pulmonary LCNEC (WHO 2021)
3. Relapse or refractory after receiving at least first-line standard therapy, or inability to tolerate first-line standard therapy
4. Eastern Cooperative Oncology Group score 0-1;
5. At least one measurable tumor lesion (other than brain metastases) according to solid tumor response criteria 1.1 (RECIST1.1)
6. Measurable lesions with an expected survival of more than 3 months;
7. Expected survival ≥12 weeks.
8. Adequate organ and bone marrow function.
9. The subjects agreed to use reliable contraceptive methods for contraception within 1 year from the signing of informed consent to reinfusion.
10. Voluntarily participate in clinical trials and sign informed consent.

Exclusion Criteria:

1. 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).
2. Have received any previous CAR-T therapy or other gene-modified cell therapy.
3. Have received any previous treatment targeting DLL3.
4. Uncontrolled pleural effusion, pericardial effusion, and ascites (uncontrolled refers to repeated drainage).
5. Untreated (including new lesions or progression after previous treatment) or symptomatic brain metastases.
6. 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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Drug: SNC115 injection; SNC115 Injection is DLL3 CART.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Shanghai Simnova Biotechnology Co.,Ltd.
• Collaborators: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: DLL3 CAR-T small cell lung cancer Lung large cell neuroendocrine carcinoma
• 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: No
• Studies a U.S. FDA-regulated device product: No