PT - JOURNAL ARTICLE AU - CHAWLA, SANT P. AU - JEFFREY, SAMANTHA AU - PANG, SKYLER S. AU - JONES, ROBIN L. AU - VAN GOOL, STEFAAN W. AU - HUBER, TIMO AU - KOSMAL, JENNIFER AU - CHAWLA, NEAL S. AU - CARTER, RHEANNA AU - SIMONE, CHARLES B. AU - NAEL, KAMBIZ AU - BRUCKNER, HOWARD AU - GATTANI, ANNA AU - SONG, PAUL Y. AU - HALL, FREDERICK L. AU - GORDON, ERLINDA M. TI - Analysis of Clinical Benefit Using DNG64-<em>CAR-V</em> Chimeric Tumor Targeted Amphotropic RNA Vector in <em>CCNG1</em> Expressing Cancers AID - 10.21873/anticanres.18091 DP - 2026 Apr 01 TA - Anticancer Research PG - 2025--2034 VI - 46 IP - 4 4099 - http://ar.iiarjournals.org/content/46/4/2025.short 4100 - http://ar.iiarjournals.org/content/46/4/2025.full SO - Anticancer Res2026 Apr 01; 46 AB - Background/Aim: Metastatic cancer is almost always fatal, with few promising clinical options. DNG64-CAR-V is an off-the-shelf, replication-incompetent Chimeric Amphotropic tumor-targeted RNA Vector encoding a cytocidal Cyclin G1 (CCNG1) inhibitor construct.Patients and Methods: CCNG1 expression level in cancer types; Clinical benefit rate or CBR [complete response (CR), partial response (PR), or stable disease (SD)], confirmed by computed tomography or magnetic resonance imaging by RECIST v1.1; Overall response rate (ORR) and incidence and severity of adverse events were assessed. Eligibility criteria included: Previously treated male or female patients ≥12 years old with advanced sarcomas and patients ≥18 years old with advanced pancreatic ductal adenocarcinoma (PDAC), breast carcinoma or ovarian adenocarcinoma; Patients were treated with DNG64-CAR-V (1.7×1010 VC 3× a week × 3 weeks/month) plus metronomic low doses of FDA approved drugs (DNG64-CAR-V+); Statistical analysis was performed with Simon 2-stage design with Type I error rate=0.1 and power=0.8. A CBR ≥30% warrants a Phase II study using DNG64-CAR-V+ for CCNG1 expressing tumors.Results: Ten subjects with CCNG1 expressing sarcomas (n=6), PDAC (n=2), breast ductal carcinoma (n=1), and ovarian adenocarcinoma (n=1) were treated with DNG64-CAR-V+. Five of 10 (50%) had PR; 9/10 (90%) had clinical benefit. Median progression-free survival was 6.7 months for sarcoma. No serious treatment-related adverse event is reported.Conclusion: A response rate of 50% and a CBR of 90% for all groups meet the Simon 2-stage threshold of CBR &gt;30%, thereby qualifying all groups for a Phase II study using DNG64-CAR-V+ in CCNG1 expressing advanced cancers.