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

NCT05699811 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-04-28

No results posted yet for this study

Summary

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.

Conditions

  • Locally Advanced or Metastatic Solid Tumors

Interventions

BIOLOGICAL

MSC-IFNα

MSC-IFNα form a dose of 2×10\^6 cells/kg, intravenous infusion every 4-6 weeks

DRUG

Nab paclitaxel

125mg/m2, intravenous infusion every 4-6 weeks

DRUG

Cyclophosphamide

200mg/m2, intravenous infusion every 4-6 weeks

DRUG

Anti-PD-1 monoclonal antibody

200mg, intravenous infusion every 4-6 weeks

Sponsors & Collaborators

  • Wuxi Sinotide New Drug Discovery Institutes

    collaborator UNKNOWN

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • WeiDong Han, PhD · Chinsese PLA Gereral Hospital

  • Yufang Shi, PhD · Wuxi Sinotide New Drug Discovery Institutes

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-23
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05699811 on ClinicalTrials.gov