SNC115 injections for patients with advanced lung cancer
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 testing a new injection called SNC115 to see if it is safe and effective for people with advanced lung cancer that hasn't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Simnova Biotechnology Co.,Ltd. Industry-sponsored |
| Drugs / interventions | Tocilizumab, CAR-T, cyclophosphamide, fludarabine |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06384482 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a first-in-human dose escalation study designed to evaluate the safety and pharmacokinetics of SNC115 injections in patients with recurrent or refractory small cell lung cancer and lung large cell neuroendocrine carcinoma. The study will enroll up to 35 participants, who will receive varying doses of the treatment based on a predetermined escalation plan. Participants will undergo a series of procedures including mononuclear cell acquisition, lymphodepletion, and follow-up assessments over a period of 1 to 5 years to monitor treatment effects and safety outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with recurrent or refractory small cell lung cancer or lung large cell neuroendocrine carcinoma who have not responded to standard therapies.
Not a fit: Patients with known allergies or contraindications to SNC115 injection will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat lung cancers.
How similar studies have performed: While this approach is novel, similar CAR-T therapies have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full 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.
Where this trial is running
Shanghai, Shanghai
- Shanghai Chest Hospital — Shanghai, Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.