NCT05699811

IFNα Expressing Mesenchymal Stromal Cells for Locally Advanced/Metastatic Solid Tumors

Recruiting now Phase 1, PHASE2 Last updated 28 April 2023

What this trial tests

Phase 1, PHASE2 trial testing MSC-IFNα in Locally Advanced or Metastatic Solid Tumors in 40 participants. Currently enrolling.

Timeline

23 February 2023

Primary endpoint
31 December 2025

31 December 2026

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	23 February 2023
Primary completion	31 December 2025
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

• MSC-IFNα — full drug profile →
• Nab paclitaxel
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Anti-PD-1 monoclonal antibody — full drug profile →

Conditions studied

• Locally Advanced or Metastatic Solid Tumors — all drugs for Locally Advanced or Metastatic Solid Tumors →

Sponsor

Chinese PLA General Hospital

Who can join

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

Sponsor's own description

The goal of this first-in-human, single-center, prospective, open-label, phase 1/2 trial is to evaluate the safety and efficacy of the interferon alpha expressing mesenchymal stromal cells (MSC-IFNα) combined with or without immunochemotherapy in patients with locally advanced/metastatic solid tumors. The main questions aimed to answer are 1) to evaluate the safety and feasibility of MSC-IFNα in the treatment of locally advanced/metastatic solid tumors;2) to evaluate the anti-tumor effects of the MSC-IFNα combined with or without immunochemotherapy in the treatment of locally advanced/metastatic solid tumors; 3) to evaluate the pharmacokinetics/pharmacodynamics of MSC-IFNα and related immune effector cells.

Publications & conference data

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

1. Stromal cells in the tumor microenvironment: accomplices of tumor progression?
   Zhao Y, Shen M, Wu L, Yang H, et al · · 2023 · cited 271× · PMID 37666813 · DOI 10.1038/s41419-023-06110-6
2. 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
3. Glioblastoma progression is hindered by melatonin-primed mesenchymal stromal cells through dynamic intracellular and extracellular reorganizations.
   Olmedo-Moreno L, Panadero-Morón C, Sierra-Párraga JM, Bueno-Fernández R, et al · · 2025 · cited 8× · PMID 40083939 · DOI 10.7150/thno.104143
4. Applications of Modified Mesenchymal Stem Cells as Targeted Systems against Tumor Cells.
   Garza Treviño EN, Quiroz Reyes AG, Delgado Gonzalez P, Rojas Murillo JA, et al · · 2024 · cited 6× · PMID 39063032 · DOI 10.3390/ijms25147791
5. Improvement of the Anticancer Efficacy of PD-1/PD-L1 Blockade: Advances in Molecular Mechanisms and Therapeutic Strategies.
   Gao P, Li X, Duan Z, Wang Y, et al · · 2025 · cited 4× · PMID 40672434 · DOI 10.1002/mco2.70274
6. The Spatiotemporal Heterogeneity of Tumor-Associated Stromal Cells: Reprogramming Plasticity to Unlock Precision Cancer Immunotherapy.
   Lv Y, Duan T, Song J, Liu S, et al · · 2026 · cited 1× · PMID 41625480 · DOI 10.34133/cancomm.0002
7. Bioinspired micro- and nanostructured systems for cancer therapy.
   Yang R, Zhang B, Fei X, Cong S, et al · · 2024 · cited 1× · PMID 39619230 · DOI 10.1002/mco2.70025
8. Mesenchymal Stromal/Stem Cells (MSCs) in Cancer Therapy: Advanced Therapeutic Strategies Towards Future Clinical Translation.
   Kucharczyk H, Tarnowski M, Tkacz M. · · 2025 · PMID 41471830 · DOI 10.3390/molecules30244808