Health TrialsbyHealthPanel

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

ConditionLocally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese PLA General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 75 years with estimated life expectancy >3 months.

Histopathological confirmed locally advanced or metastatic solid tumors including, but not limited to, lung cancer, breast cancer, colorectal cancer, hepatocellular carcinoma, and sarcomas.

Failed to at least first-line and second-line treatments or initially diagnosed locally advanced/metastatic solid tumors that have no National Comprehensive Cancer Network(NCCN) guideline-recommended therapy.

Have at least one measurable target lesion.

Disqualifiers

Active, known, or suspected autoimmune diseases.

Known brain metastases or active central nervous system (CNS). Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms, and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.

Subjects are being treated with either corticosteroid (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.

History of psychiatric disorders including depression, suicidality, and mania.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MSC-IFNα

    Biological/Vaccine

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

  • Nab paclitaxel

    Drug

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

  • Cyclophosphamide

    Drug

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

  • Anti-PD-1 monoclonal antibody

    Drug

    200mg, intravenous infusion every 4-6 weeks

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: MSC-IFNα monotherapyExperimental treatment 1 intervention
Group B: MSC-IFNα combined with immunochemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Incidence of treatment related adverse events(TRAE)

Treatment related adverse events (TRAE) are defined as any medical events since the initiation of MSC-IFNα therapy. All TRAEs will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE V5.0)

Time frame
Up to 12 months since the initiation of MSC-IFNα therapy

Secondary outcomes

1

Objective response rate (ORR) of MSC-IFNα combined with or without immunochemotherapy

Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to MSC-IFNα treatment according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or immune RECIST (iRECIST)

Time frame
Up to 12 months since the initiation of MSC-IFNα therapy
2

Progression free survival (PFS) of MSC-IFNα combined with or without immunochemotherapy

Progression free survival (PFS) is defined as the time from enrollment of the study to disease progression or death from any cause.

Time frame
Up to 12 months since the initiation of MSC-IFNα therapy
3

Duration of response(DOR) of MSC-IFNα combined with or without immunochemotherapy

Duration of response(DOR) is defined as the length of time that a tumor continues to respond to treatment without the cancer growing or spreading

Time frame
Up to 12 months since the initiation of MSC-IFNα therapy
4

Overall survival (OS) of MSC-IFNα combined with or without immunochemotherapy

Overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence

Time frame
Up to 12 months since the initiation of MSC-IFNα therapy

Other outcomes

1

Allograft MSC-IFNa cells in peripheral blood and in tumor microenvironments.

Engineered MSC-IFNa will be periodically monitored by quantitative polymerase chain reaction (qPCR)

Time frame
Up to 12 months since the initiation of MSC-IFNα therapy
2

Serum interferon-α level after infusion of MSC-IFNα

Serum interferon-α level will be dynamically monitored by enzyme-linked immunosorbent assay (ELISA)

Time frame
Up to 12 months since the initiation of MSC-IFNα therapy
3

Serum interferon-β level after infusion of MSC-IFNα

Serum interferon-β level will be dynamically monitored by enzyme-linked immunosorbent assay (ELISA)

Time frame
Up to 12 months since the initiation of MSC-IFNα therapy
4

Serum interleukin-2 level after infusion of MSC-IFNα

Serum interleukin-2 level will be dynamically monitored by enzyme-linked immunosorbent assay (ELISA)

Time frame
Up to 12 months since the initiation of MSC-IFNα therapy

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese PLA General Hospital

Lead sponsor

Wuxi Sinotide New Drug Discovery Institutes

Collaborator

Source ClinicalTrials.gov
Apply now