A phase I clinical trial of oncolytic adenovirus mediated suicide and interleukin-12 gene therapy in patients with recurrent localized prostate adenocarcinoma

• Published in: PloS one Vol. 18; no. 9; p. e0291315
• Main Authors: Nyati, Shyam, Stricker, Hans, Barton, Kenneth N., Li, Pin, Elshaikh, Mohamed, Ali, Haythem, Brown, Stephen L., Hwang, Clara, Peabody, James, Freytag, Svend O., Movsas, Benjamin, Siddiqui, Farzan
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 15.09.2023; Public Library of Science (PLoS)
• Subjects: Adenocarcinoma; Adenocarcinoma - therapy; Adenoviridae; Adenoviruses; Antigens; Biology and life sciences; Cancer; Cancer therapies; Care and treatment; Clinical trials; Complications and side effects; CXCL10 protein; Cytokines; Cytotoxicity; Diagnosis; Diseases; Dose dependency; Evaluation; Gene therapy; Genes; Genes, Transgenic, Suicide; Genetic aspects; Genetic research; Genetic Therapy - adverse effects; Health aspects; Humans; Immune system; Interleukin 12; Interleukin-12 - genetics; Interleukins; Kinases; Leukocytes, Mononuclear; Leukopenia; Male; Medicine and Health Sciences; Oncolysis; Oncolytic Virotherapy; Patient outcomes; Patients; Peripheral blood mononuclear cells; Product development; Prostate; Prostate cancer; Prostatic Neoplasms - therapy; Radiation therapy; Relapse; Replication; Research and Analysis Methods; Suicidal behavior; Suicide; Suicide genes; Toxicity; γ-Interferon; United States

In a phase I dose escalation and safety study (NCT02555397), a replication-competent oncolytic adenovirus expressing yCD, TK and hIL-12 (Ad5-yCD/ mut TK SR39 rep -hIL-12) was administered in 15 subjects with localized recurrent prostate cancer (T1c-T2) at increasing doses (1 × 10 10 , to 1 × 10 12 v...