NCT05914376

Safety of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Tumors

Active, enrolled Phase 1 Last updated 27 February 2026

What this trial tests

Phase 1 trial testing Recombinant human IL-21-expressing oncolytic vaccinia virus injection in Advanced Solid Tumors in 24 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 July 2023

Primary endpoint
2 July 2025

10 June 2027

Quick facts

Lead sponsor	Hangzhou Converd Co., Ltd.
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	5 July 2023
Primary completion	2 July 2025
Estimated completion	10 June 2027
Sites	2 locations across China

Drugs / interventions tested

• Recombinant human IL-21-expressing oncolytic vaccinia virus injection — full drug profile →

Conditions studied

• Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

Hangzhou Converd Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to evaluate the safety, tolerance, pharmacokinetics, and biological properties of recombinant human IL-21-expressing oncolytic vaccinia virus injection (hV01) in patients with advanced solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inflammation in cancer: therapeutic opportunities from new insights.
   Xie Y, Liu F, Wu Y, Zhu Y, et al · · 2025 · cited 53× · PMID 39994787 · DOI 10.1186/s12943-025-02243-8
2. Recent progress in combination therapy of oncolytic vaccinia virus.
   Mirbahari SN, Da Silva M, Zúñiga AIM, Kooshki Zamani N, et al · · 2024 · cited 25× · PMID 38558795 · DOI 10.3389/fimmu.2024.1272351
3. Therapeutic potential of interleukin-21 in cancer.
   Isvoranu G, Chiritoiu-Butnaru M. · · 2024 · cited 18× · PMID 38638431 · DOI 10.3389/fimmu.2024.1369743
4. Charting a killer course to the solid tumor: strategies to recruit and activate NK cells in the tumor microenvironment.
   Portillo AL, Monteiro JK, Rojas EA, Ritchie TM, et al · · 2023 · cited 12× · PMID 38022679 · DOI 10.3389/fimmu.2023.1286750
5. Cancer vaccines: an update on recent achievements and prospects for cancer therapy.
   Chekaoui A, Garofalo M, Gad B, Staniszewska M, et al · · 2024 · cited 8× · PMID 39720956 · DOI 10.1007/s10238-024-01541-7
6. Recent advances of engineered oncolytic viruses-based combination therapy for liver cancer.
   Zhang J, Xiao Y, Zhang J, Yang Y, et al · · 2024 · cited 8× · PMID 38167076 · DOI 10.1186/s12967-023-04817-w
7. Recent advances in oncolytic virus combined immunotherapy in tumor treatment.
   Zhou X, Hu S, Wang X. · · 2025 · cited 4× · PMID 40821119 · DOI 10.1016/j.gendis.2025.101599
8. Oncolytic viruses: advanced strategies in cancer therapy.
   Xiao D, Zhang H, Liu Y, Li Y, et al · · 2026 · cited 2× · PMID 41639062 · DOI 10.1038/s41392-025-02343-3