BioTTT001 / Beijing Bio-Targeting Therap, Luhe Hospital - LARVOL DELTA

A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Recurrent/Progressive High-grade Glioma. (clinicaltrials.gov) - P1/2 | N=30 | Enrolling by invitation | Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd | Trial completion date: Aug 2026 ➔ Jul 2027 | Trial primary completion date: Aug 2026 ➔ Jul 2027

Trial completion date • Trial primary completion date • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor

A Clinical Study to Explore the Safety, Tolerability, and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) Combined With Neoadjuvant Treatment for Locally Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd | N=27 ➔ 0 | Enrolling by invitation ➔ Withdrawn

Enrollment change • Trial withdrawal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Enrolling by invitation | Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd | Trial completion date: Jan 2026 ➔ Jun 2026 | Trial primary completion date: Sep 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Solid Tumor • IL12A

Clinical Study of a Novel Oncolytic Virus Ad-TD-nsIL12 in the Treatment of Primary High-grade Glioma (clinicaltrials.gov) - P1/2 | N=40 | Enrolling by invitation | Sponsor: Xiaorong Wu

New P1/2 trial • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor

A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Enrolling by invitation | Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd | Trial primary completion date: Apr 2026 ➔ Sep 2025

Trial primary completion date • Solid Tumor • IL12A

A Clinical Study to Explore the Safety, Tolerability, and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) Combined With Neoadjuvant Treatment for Locally Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=27 | Enrolling by invitation | Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd

New P1 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

The oncolytic adenovirus Ad-TD-nsIL12 in primary or progressive pediatric IDH wild-type diffuse intrinsic pontine glioma results of two phase I clinical trials. (PubMed, Nat Commun) - P1 | "Both groups showed increased lymphocytes post-treatment, but only Group A decreased after radiotherapy. These trials confirmed the safety of Ad-TD-nsIL12 and provided preliminary efficacy evidence, offering insights for future clinical applications in DIPG."

Journal • P1 data • Brain Cancer • Diffuse Intrinsic Pontine Glioma • Glioma • Oncology • Pediatrics • Solid Tumor

Phase I study of oncolytic adenovirus BioTTT001 in patients with peritoneal carcinomatosis. (ASCO 2025) - P1 | "The intraperitoneal infusion of BioTTT001 for the treatment of peritoneal metastatic cancer was well tolerated with encouraging clinical benefit in pelvic peritoneal metastasis and MA controlling. This warrants further clinical investigation."

Clinical • Oncolytic virus • P1 data • Colorectal Cancer • Fatigue • Gastric Cancer • Oncology • Ovarian Cancer • Pain • Peritoneal Cancer • CD8 • IL12A • MUC16

A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients with Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Enrolling by invitation | Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Oncology • Solid Tumor

A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients with Recurrent/progressive High-grade Glioma. (clinicaltrials.gov) - P1/2 | N=30 | Enrolling by invitation | Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd

New P1/2 trial • Brain Cancer • CNS Tumor • Glioma • Malignant Glioma • Oncology • Solid Tumor

Non-secreting IL12 expressing oncolytic adenovirus Ad-TD-nsIL12 in recurrent high-grade glioma: a phase I trial. (PubMed, Nat Commun) - P1 | "Complete response (according to Response Assessment in Neuro-Oncology Criteria) in one patient, a partial response in one patient and post-treatment infiltrations of CD4+ and CD8 + T cells into the tumour were documented during this trial. In conclusion, Ad-TD-nsIL12 has demonstrated safety and preliminary efficacy in patients with recurrent high-grade glioma."

Journal • Oncolytic virus • P1 data • Brain Cancer • CNS Disorders • CNS Tumor • Epilepsy • Glioma • Malignant Glioma • Oncology • Solid Tumor • Ventriculomegaly • CD4 • CD8 • IL12A

Treatment of intracranial inflammatory myofibroblastic tumor with PD-L1 inhibitor and novel oncolytic adenovirus Ad-TD-nsIL12: a case report and literature review. (PubMed, Front Immunol) - "In this case report, we present a middle-aged male who received PD-1 inhibitor and oncolytic adenovirus (Ad-TD-nsIL12) treatment after IIMT resection surgery. This successful approach provides a new direction for the treatment of IIMT."

IO biomarker • Journal • Oncolytic virus • Review • Oncology

Initial results from phase I trial of a novel oncolytic adenovirus Ad-TD-nsIL12 in recurrent glioblastoma connecting to ventricular system. (ASCO 2024) - "AD-TD-nsIL12 treatment was safe and effective in patients with rGBM and warrants examination in a phase II clinical study."

Oncolytic virus • P1 data • Brain Cancer • CNS Disorders • CNS Tumor • Epilepsy • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8

A viral attack on brain tumors: the potential of oncolytic virus therapy. (PubMed, J Neurovirol) - "Furthermore, the discovery and creation of new OVs that can seamlessly integrate gene therapy strategies, such as cytotoxic, anti-angiogenic, and immunostimulatory, are promising advancements. This review presents an overview of the latest advancements in OVs transduction for brain cancer, focusing on the safety and effectiveness of G207, G47Δ, M032, rQNestin34.5v.2, C134, DNX-2401, Ad-TD-nsIL12, NSC-CRAd-S-p7, TG6002, and PVSRIPO. These are evaluated in both preclinical and clinical models of various brain tumors."

Journal • Oncolytic virus • Review • Brain Cancer • Gene Therapies • Oncology • Solid Tumor

A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: China Medical University, China

New P2 trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: China Medical University, China

New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd

New P1 trial • Oncolytic virus • Oncology • Solid Tumor

Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Capital Medical University

New P1 trial • Oncolytic virus • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Glioma • Oncology • Pediatrics • Solid Tumor

Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Capital Medical University

New P1 trial • Oncolytic virus • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Glioma • Oncology • Pediatrics • Solid Tumor