SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma

NCT06384482 | Recruiting Phase 1

• 1 other identifier: SNC115-DLL3 CART-101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma

Keywords

DLL3 CAR-T small cell lung cancer Lung large cell neuroendocrine carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• -Efficacy of SNC115 Injection

  Day 1 through Month 18

• -Efficacy of SNC115 Injection

  Day 1 through Month 18

• -Efficacy of SNC115 Injection

  Day 1 through Month 18

• -Efficacy of SNC115 Injection

  Day 1 through Month 18

• -Efficacy of SNC115 Injection

  Day 1 through Month 18

Other Outcomes (6)

• -PK characteristic of SNC115 Injection.

  Day 1 through Month 18

• -PK characteristic of SNC115 Injection.

  Day 1 through Month 18

• PK characteristic of SNC115 Injection.

  Day 1 through Month 18

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: SNC115 injection

Interventions

SNC115 injection DRUG

SNC115 Injection is DLL3 CART.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Simnova Biotechnology Co.,Ltd.: lead
• Shanghai Chest Hospital: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 25, 2024
• Study Start: April 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CN (1)