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

NCT ID: NCT06384482

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-12-30

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

SNC115 injection

Intervention Type: DRUG

SNC115 Injection is DLL3 CART.

Interventions

SNC115 injection

SNC115 Injection is DLL3 CART.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: collaborator

Shanghai Simnova Biotechnology Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Hua Zhong, MD/PhD

Role: primary

ctqxkyy@163.com; eddiedong8@hotmail.com

021-22200000

Other Identifiers

SNC115-DLL3 CART-101

Identifier Type: -

Identifier Source: org_study_id