Locally Advanced or Metastatic Solid TumorsPhase 1/2NCT05699811
IFNα Expressing Mesenchymal Stromal Cells for Locally Advanced/Metastatic Solid Tumors
A Phase 1/2 study testing MSC-IFNα, Nab paclitaxel and Cyclophosphamide in people with Locally Advanced or Metastatic Solid Tumors, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- MSC-IFNα, Nab paclitaxel and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2023to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study.
- Have an Eastern Cooperative Oncology Group performance status (ECOG) of 0 to 2 at the time of enrollment.
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- Have adequate organ function, which should be confirmed within 2 weeks prior to the first dose of study drugs.
- Previous treatment with anti-PD-1/PD-L1 antibodies is allowed.
- Ability to understand and sign a written informed consent document.
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and up to 90 days after the last dose of the drug.
Who cannot join
- 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.
- History of allergy or intolerance to study drug components.
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
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- Uncontrolled concurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia), or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.
- History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before enrollment, and a negative result must be documented.
- Previous or concurrent cancer within 3 years prior to treatment start.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Biotherapeutic, Chinese PLA General Hospital
Beijing
WeiDong Han, Ph.D, +86-10-66937463, hanwdrsw@163.com
GuangHua Rong, Ph.D, +86-10-66947473, guanghua.rong@gmail.com
About this study
Official title: Phase I/II Trial of Allograft Engineered MSC-IFNα Combined With or Without Immunochemotherapy for Locally Advanced/Metastatic Solid Tumors
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.
Read the detailed description
[Introduction] Mesenchymal Stromal Cells (MSCs) have been shown to home to the sites of injury or damage and secrete immunomodulatory factors. This feature makes MSCs an ideal carrier to deliver drugs or cytokines to the tumor microenvironment (TME) and therefore have a potential therapeutic role in cancer treatment.
Interferon(IFN) has been widely used for cancer treatment for its pleiotropic antitumor effects. IFN receptor signals mediate intrinsic and extrinsic effects on tumor cells and the TME, including tumor-infiltrating lymphocytes as well as tumor-associated stroma. Additionally, IFNs also exert direct intrinsic antitumor effects including inhibition of cell proliferation by inducing cell cycle arrest, cell death via apoptosis and ferroptosis, cell differentiation, and senescence, thus acting as a tumor suppressor. Accumulating evidence suggests that IFNs play critical roles in cancer immunotherapy, however, the variations in responses and the adverse effects have reduced their popularity in clinical applications. New IFN-based strategies should be considered as a high priority.
Our team has developed a protocol to genetically express IFNα in bone marrow-derived MSCs. In vitro and in vivo experiments have shown that the MSC-IFNα cells possess a potent ability to home to TME and to secret IFNα. By changing TME, MSC-IFNα induces strong anti-tumor effects in several cancer types in animal models. In addition, preliminary data also indicated that the combination of IFNα-MSCs with chemotherapy and/or programmed death-1(PD-1)/programmed death-ligand 1(PD-L1)blockade may bring an even stronger anti-tumor immunity.
In this study, by producing MSC-IFNα cells with human umbilical-cord-derived mesenchymal stromal cells (hUC-MSCs, passage 5 to passage 7), the investigators plan to conduct a first-in-human, prospective, open-label, phase 1/2 trial to evaluate the safety and efficacy of MSC-IFNα combined with or without immunochemotherapy in patients with locally advanced/metastatic solid tumors.
[Study design] Phase 1 Arm 1. Safety evaluation of MSC-IFNα monotherapy A total of 3-9 subjects will be enrolled for the safety evaluation of MSC-IFNα monotherapy. All treatment-related adverse events (TRAE) will be recorded for at least 28 days after cell infusion. Subjects with any grade 3-4 TRAE that lasts for 7 days or more within the 28 days after infusion will be determined as treatment intolerance (TI).
The first 3 subjects will receive MSC-IFNα infusion 1-4 times every 4-6 weeks at a dose of 2×10^6 cells/kg. If TI occurred in any of the 3 subjects, another 3 subjects will be enrolled and received a 70% reduced MSC-IFNα dose (i.e. 6×10^5 cells/kg, 2x10^5/kg, and so on) until tolerable dose (no TI in all 3 subjects) was reached.
Arm 2. Safety and efficacy evaluation of MSC-IFNα combined with immunochemotherapy.
A total of 3-9 subjects will be enrolled and receive MSC-IFNα infusion (tolerable dose determined in Arm 1) every 4-6 weeks for 4 cycles. Immunochemotherapy, namely nab-paclitaxel (125 mg/m2, 5 days before cell infusions), cyclophosphamide (200 mg/m2,4 days before cell infusions) and anti-PD-1 antibody (200mg, 7 days after infusion) will be given. From the 5th cycle, subjects will receive MSC-IFNα combined with anti-PD-1 antibody (200mg, 7 days after infusion) every 4-6 weeks for another 4 cycles for efficacy consolation. From the 9th cycle, subjects will receive anti-PD-1 antibody (200mg) alone every 3 weeks for another 4 cycles for efficacy maintenance. The safety, efficacy, and other required data will be collected and the optimized combined regimen (OCR) of MSC-IFNα and immunochemotherapy will be determined. MSC-IFNα related AE will be continuously monitored in this arm, and reduced MSC-IFNα dose will be considered if necessary.
Phase 2 A total of 10-30 subjects will be enrolled and received the OCR determined in the phase 1 of the trial. The safety, efficacy, and other required data will be collected.
During the treatment, efficacy in all subjects will be assessed at baseline and every 8 weeks thereafter until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first.
During post-treatment follow-up, efficacy and TRAEs in all subjects will be assessed every 12 weeks until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first.
- Being tested
- MSC-IFNα, Nab paclitaxel, Cyclophosphamide, Anti-PD-1 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC-IFNαBiological
MSC-IFNα form a dose of 2×10^6 cells/kg, intravenous infusion every 4-6 weeks
Nab paclitaxelDrug
Also called Abraxane
125mg/m2, intravenous infusion every 4-6 weeks
CyclophosphamideDrug
200mg/m2, intravenous infusion every 4-6 weeks
Anti-PD-1 monoclonal antibodyDrug
Also called Toripalimab Injection, Sintilimab Injection, Camrelizumab Injection, Tislelizumab Injection
200mg, intravenous infusion every 4-6 weeks
| Study group | Role | What they receive |
|---|---|---|
| MSC-IFNα monotherapy | Experimental | Subjects will be enrolled for safety evaluation of MSC-IFNα monotherapy. Subjects will receive MSC-IFNα infusion from a dose of 2×10^6 cells/kg 1-4 times every 4-6 weeks. All treatment-related adverse events(TRAE) will be recorded for at least 28 days after the cell infusion. Receives: Biological: MSC-IFNα |
| MSC-IFNα combined with immunochemotherapy | Experimental | Subjects will be enrolled and received MSC-IFNα combined with immunochemotherapy, namely nab-paclitaxel (125 mg/m2, 5 days before infusion), cyclophosphamide (200 mg/m2,4 days before infusion) and anti-PD-1 antibody (200mg, 7 days after infusion) for 4 cycles.
From the 5th cycle, subjects will receive MSC-IFNα combined with anti-PD-1 antibody every 4-6 weeks for another 4 cycles for efficacy consolation. From the 9th cycle, subjects will receive anti-PD-1 antibody alone every 3 weeks for another 4 cycles for efficacy maintenance. Receives: Biological: MSC-IFNα; Drug: Nab paclitaxel; Drug: Cyclophosphamide; Drug: Anti-PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 12 months since the initiation of MSC-IFNα therapy
Secondary outcomes (4)
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)
Measured: Up to 12 months since the initiation of MSC-IFNα therapy
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.
Measured: Up to 12 months since the initiation of MSC-IFNα therapy
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
Measured: Up to 12 months since the initiation of MSC-IFNα therapy
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
Measured: Up to 12 months since the initiation of MSC-IFNα therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start23 Feb 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuxi Sinotide New Drug Discovery Institutes
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- WeiDong Han, PhD, Principal investigator, Chinsese PLA Gereral HospitalYufang Shi, PhD, Study chair, Wuxi Sinotide New Drug Discovery Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699811
- Sponsor's protocol ID
- CHN-PLAGH-BT-078
- Status last verified
- Apr 2023
- First submitted
- 7 Jan 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Allograft Engineered MSC-IFNα Combined With or Without Immunochemotherapy for Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05699811
- Acronym / sponsor ID
- CHN-PLAGH-BT-078
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Wuxi Sinotide New Drug Discovery Institutes
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
[Introduction] Mesenchymal Stromal Cells (MSCs) have been shown to home to the sites of injury or damage and secrete immunomodulatory factors. This feature makes MSCs an ideal carrier to deliver drugs or cytokines to the tumor microenvironment (TME) and therefore have a potential therapeutic role in cancer treatment.
Interferon(IFN) has been widely used for cancer treatment for its pleiotropic antitumor effects. IFN receptor signals mediate intrinsic and extrinsic effects on tumor cells and the TME, including tumor-infiltrating lymphocytes as well as tumor-associated stroma. Additionally, IFNs also exert direct intrinsic antitumor effects including inhibition of cell proliferation by inducing cell cycle arrest, cell death via apoptosis and ferroptosis, cell differentiation, and senescence, thus acting as a tumor suppressor. Accumulating evidence suggests that IFNs play critical roles in cancer immunotherapy, however, the variations in responses and the adverse effects have reduced their popularity in clinical applications. New IFN-based strategies should be considered as a high priority.
Our team has developed a protocol to genetically express IFNα in bone marrow-derived MSCs. In vitro and in vivo experiments have shown that the MSC-IFNα cells possess a potent ability to home to TME and to secret IFNα. By changing TME, MSC-IFNα induces strong anti-tumor effects in several cancer types in animal models. In addition, preliminary data also indicated that the combination of IFNα-MSCs with chemotherapy and/or programmed death-1(PD-1)/programmed death-ligand 1(PD-L1)blockade may bring an even stronger anti-tumor immunity.
In this study, by producing MSC-IFNα cells with human umbilical-cord-derived mesenchymal stromal cells (hUC-MSCs, passage 5 to passage 7), the investigators plan to conduct a first-in-human, prospective, open-label, phase 1/2 trial to evaluate the safety and efficacy of MSC-IFNα combined with or without immunochemotherapy in patients with locally advanced/metastatic solid tumors.
[Study design] Phase 1 Arm 1. Safety evaluation of MSC-IFNα monotherapy A total of 3-9 subjects will be enrolled for the safety evaluation of MSC-IFNα monotherapy. All treatment-related adverse events (TRAE) will be recorded for at least 28 days after cell infusion. Subjects with any grade 3-4 TRAE that lasts for 7 days or more within the 28 days after infusion will be determined as treatment intolerance (TI).
The first 3 subjects will receive MSC-IFNα infusion 1-4 times every 4-6 weeks at a dose of 2×10^6 cells/kg. If TI occurred in any of the 3 subjects, another 3 subjects will be enrolled and received a 70% reduced MSC-IFNα dose (i.e. 6×10^5 cells/kg, 2x10^5/kg, and so on) until tolerable dose (no TI in all 3 subjects) was reached.
Arm 2. Safety and efficacy evaluation of MSC-IFNα combined with immunochemotherapy.
A total of 3-9 subjects will be enrolled and receive MSC-IFNα infusion (tolerable dose determined in Arm 1) every 4-6 weeks for 4 cycles. Immunochemotherapy, namely nab-paclitaxel (125 mg/m2, 5 days before cell infusions), cyclophosphamide (200 mg/m2,4 days before cell infusions) and anti-PD-1 antibody (200mg, 7 days after infusion) will be given. From the 5th cycle, subjects will receive MSC-IFNα combined with anti-PD-1 antibody (200mg, 7 days after infusion) every 4-6 weeks for another 4 cycles for efficacy consolation. From the 9th cycle, subjects will receive anti-PD-1 antibody (200mg) alone every 3 weeks for another 4 cycles for efficacy maintenance. The safety, efficacy, and other required data will be collected and the optimized combined regimen (OCR) of MSC-IFNα and immunochemotherapy will be determined. MSC-IFNα related AE will be continuously monitored in this arm, and reduced MSC-IFNα dose will be considered if necessary.
Phase 2 A total of 10-30 subjects will be enrolled and received the OCR determined in the phase 1 of the trial. The safety, efficacy, and other required data will be collected.
During the treatment, efficacy in all subjects will be assessed at baseline and every 8 weeks thereafter until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first.
During post-treatment follow-up, efficacy and TRAEs in all subjects will be assessed every 12 weeks until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC-IFNα monotherapy | Experimental | Biological: MSC-IFNαSubjects will be enrolled for safety evaluation of MSC-IFNα monotherapy. Subjects will receive MSC-IFNα infusion from a dose of 2×10^6 cells/kg 1-4 times every 4-6 weeks. All treatment-related adverse events(TRAE) will be recorded for at least 28 days after the cell infusion. |
| MSC-IFNα combined with immunochemotherapy | Experimental | Biological: MSC-IFNα, Drug: Nab paclitaxel, Drug: Cyclophosphamide, Drug: Anti-PD-1 monoclonal antibodySubjects will be enrolled and received MSC-IFNα combined with immunochemotherapy, namely nab-paclitaxel (125 mg/m2, 5 days before infusion), cyclophosphamide (200 mg/m2,4 days before infusion) and anti-PD-1 antibody (200mg, 7 days after infusion) for 4 cycles. From the 5th cycle, subjects will receive MSC-IFNα combined with anti-PD-1 antibody every 4-6 weeks for another 4 cycles for efficacy consolation. From the 9th cycle, subjects will receive anti-PD-1 antibody alone every 3 weeks for another 4 cycles for efficacy maintenance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study.
Key exclusion criteria (10 listed)
- 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.
- History of allergy or intolerance to study drug components.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSC-IFNαMSC-IFNα form a dose of 2×10^6 cells/kg, intravenous infusion every 4-6 weeks | Biological | MSC-IFNα combined with immunochemotherapy, MSC-IFNα monotherapy |
| Nab paclitaxelAlso: Abraxane125mg/m2, intravenous infusion every 4-6 weeks | Drug | MSC-IFNα combined with immunochemotherapy |
| Cyclophosphamide200mg/m2, intravenous infusion every 4-6 weeks | Drug | MSC-IFNα combined with immunochemotherapy |
| Anti-PD-1 monoclonal antibodyAlso: Toripalimab Injection, Sintilimab Injection, Camrelizumab Injection, Tislelizumab Injection200mg, intravenous infusion every 4-6 weeks | Drug | MSC-IFNα combined with immunochemotherapy |
Primary outcome
Incidence of treatment related adverse events(TRAE)
Time frame: Up to 12 months since the initiation of MSC-IFNα therapy
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)
4 secondary outcomes
Objective response rate (ORR) of MSC-IFNα combined with or without immunochemotherapy
Time frame: Up to 12 months since the initiation of MSC-IFNα therapy
Progression free survival (PFS) of MSC-IFNα combined with or without immunochemotherapy
Time frame: Up to 12 months since the initiation of MSC-IFNα therapy
Duration of response(DOR) of MSC-IFNα combined with or without immunochemotherapy
Time frame: Up to 12 months since the initiation of MSC-IFNα therapy
Overall survival (OS) of MSC-IFNα combined with or without immunochemotherapy
Time frame: Up to 12 months since the initiation of MSC-IFNα therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- In vitro and in vivo studies of MSC-IFN-αLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
WeiDong Han, PhD principal investigator
Chinsese PLA Gereral Hospital
Yufang Shi, PhD study chair
Wuxi Sinotide New Drug Discovery Institutes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSC-IFNα, Nab paclitaxel and Cyclophosphamide in people with Locally Advanced or Metastatic Solid Tumors, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WeiDong Han, PhD (010-66937231, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment related adverse events(TRAE) (time frame: Up to 12 months since the initiation of MSC-IFNα therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.