RT Journal Article
SR Electronic
T1 Analysis of Clinical Benefit Using DNG64-<em>CAR-V</em> Chimeric Tumor Targeted Amphotropic RNA Vector in <em>CCNG1</em> Expressing Cancers
JF Anticancer Research
JO Anticancer Res
FD International Institute of Anticancer Research
SP 2025
OP 2034
DO 10.21873/anticanres.18091
VO 46
IS 4
A1 CHAWLA, SANT P.
A1 JEFFREY, SAMANTHA
A1 PANG, SKYLER S.
A1 JONES, ROBIN L.
A1 VAN GOOL, STEFAAN W.
A1 HUBER, TIMO
A1 KOSMAL, JENNIFER
A1 CHAWLA, NEAL S.
A1 CARTER, RHEANNA
A1 SIMONE, CHARLES B.
A1 NAEL, KAMBIZ
A1 BRUCKNER, HOWARD
A1 GATTANI, ANNA
A1 SONG, PAUL Y.
A1 HALL, FREDERICK L.
A1 GORDON, ERLINDA M.
YR 2026
UL http://ar.iiarjournals.org/content/46/4/2025.abstract
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.