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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06384482
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Simnova Biotechnology Co.,Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Single Arm

Interventions

Drug: - SNC115 injection

SNC115 Injection is DLL3 CART.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shanghai Chest Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Chest Hospital

Shanghai, Shanghai, 200030

Site Contact

Hua Zhong, MD/PhD

ctqxkyy@163.com; eddiedong8@hotmail.com

021-22200000

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