SNC115 / Shanghai Simnova Bio - LARVOL DELTA

Safety, pharmacokinetic, and preliminary efficacy of SNC115 in patients with relapsed/refractory small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC): A phase 1 study. (ASCO 2026) - P1 | "Following leukapheresis and a 3-day lymphodepletion regimen (fludarabine/cyclophosphamide), pts received a single infusion of SNC115 at one of five planned dose levels (DL): 1.0×10^5 (DL1), 3.0×10^5 (DL2), 1.0×10^6 (DL3), 3.0×10^6 (DL4), and 6.0×10^6 (DL5) CAR+ T cells/kg...CRS occurred in 3 pts (DL1: 1pt, DL4: 2pts), all Grade 1 or 2 and resolved with tocilizumab/corticosteroids... SNC115 demonstrated a manageable safety profile and encouraging preliminary antitumor activity in heavily pretreated pts with SCLC. The absence of DLTs and ICANS, combined with low-grade transient CRS, supports continued dose escalation. These early efficacy signals suggest that SNC115 may provide a novel therapeutic avenue for R/R SCLC."

Clinical • P1 data • PK/PD data • Endocrine Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • CD70 • DLL3

A single‑arm, open‑label, dose‑finding clinical study to evaluate the safety and pharmacokinetic profile of SNC115 in patients with extensive‑stage small cell lung cancer (ES‑SCLC) (ChiCTR) - P=N/A | N=30 | Sponsor: Chinese Academy of Medical Sciences Cancer Hospital; National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Me

New trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD70 • DLL3

SNC115 in patients with relapsed/refractory small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC): Safety, pharmacokinetic, and preliminary efficacy results from a phase I study (ELCC 2026) - P1 | "The Subjects will undergo leukapheresis and lymphodepletion (LD) chemotherapy with a three-day fludarabine plus cyclophosphamide regimen...CRS occurred in 1 patient each in DL1 and DL4, both cases which were Grade 1 and rapidly resolved following the administration of tocilizumab...The expansion of CAR-T cells was detected by qPCR, and peaked at 7 days post-infusion, with Cmax ranging from 69 to 4056 copies/μg DNA.Conclusions SNC115 demonstrated a favorable safety and tolerability profile with no DLTs or ICANS observed, and mild, reversible CRS, warranting further investigation into subsequent higher dose levels. Preliminary signals of efficacy were also identified."

Clinical • P1 data • PK/PD data • Large Cell Carcinoma • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD70 • DLL3

SNC115 in patients with relapsed/refractory small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC): Safety, pharmacokinetic, and preliminary efficacy results from a phase 1 study [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Clinical • P1 data • PK/PD data • Endocrine Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Shanghai Simnova Biotechnology Co.,Ltd.

New P1 trial • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor