Advanced and Relapsed Solid TumorsPhase 1NCT07356856
Efficacy and Safety of Microtransplantation for Advanced and Relapsed Solid Tumors
A Phase 1 study testing MST in people with Advanced and Relapsed Solid Tumors, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 3 sites in China.
Trial summary
In this study, microtransplantation (MST) will be administrated to patients diagnosed with advanced / relapsed solid tumors to assess the therapeutic efficacy and safety of conventional chemotherapy in combination with MST for the treatment of advanced/relapsed solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Advanced and Relapsed Solid Tumors
- What is being tested?
- MST
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesChina
- Study dates
- 15 Jan 2026to 1 Jun 2028
- Phase
- Phase 1
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are 18 to 90 years old, regardless of gender or race;
- Advanced / relapsed solid tumors (small cell lung cancer, ovarian cancer, cervical cancer, gastric and colorectal cancer, sarcoma, head and neck tumor, etc.) are confirmed by clinical or histopathological diagnosis;
- More than two kinds of tumors are allowed;
- Karnofsky score ≥ 40, ECoG physical status ≤ 3;
- There are measurable lesions;
Who cannot join
- The researchers considered patients who were not suitable to participate in this experiment；
- Patients with mental disorders；
- Patients who refuse to cooperate with the treatment；
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Innovvy(Beijing) Biomedical Technology Co., Ltd
Haidian, Beijing Municipality
yajing Huang, Professor, 86-15811031508, huangyajing@innovvy.com
Minzu Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
huiqin Wei, Professor, 86-13978676174, 99415185@qq.com
The First People's Hospital of Nanning
Nanning, Guangxi
Xiang Lu, Professor, 86-18077107296, 2584779171@qq.com
Xiang Lu, Professor
About this study
In this study, microtransplantation (MST) will be administrated to patients diagnosed with advanced / relapsed solid tumors to assess the therapeutic efficacy and safety of conventional chemotherapy in combination with MST for the treatment of advanced/relapsed solid tumors.
Read the detailed description
In this study, the eligible patients will receive MST treatment following conventional chemotherapy, MST is the infusion of G-PBMCs after chemotherapy. G-PBMCs are peripheral blood mononuclear cells from HLA mismatched unrelated donors mobilized by granulocyte colony-stimulating factor (G-CSF).
Based on the patient's medical history, current tumor assessment results, and the latest cancer treatment guidelines, an individualized chemotherapy plan for the patient is formulated through discussions among more than three oncologists. After each course of treatment, all relevant indicators, including efficacy and safety measures are evaluated.
Patients will receive all treatment for four courses, with an interval of 21 to 28 days. After completing all the treatment courses, the patient will enter the evaluation stage. Patients who have entered the evaluation stage are permitted to receive any treatments, including symptomatic support treatment, after the completion of treatment or withdrawal from the study.
- Conditions
- Advanced and Relapsed Solid Tumors
- Being tested
- MST
- Keywords
- microtransplantation, solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSTBiological
conventional chemotherapy with microtransplantation(MST). Microtransplantation, which is the infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood mononuclear cells (GPBMC)
| Study group | Role | What they receive |
|---|---|---|
| microtransplantation; MST | Experimental | conventional chemotherapy with microtransplantation Receives: Biological: MST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Events
Treatment related mortality
Measured: 1 month
time of hematopoietic recovery
Absolute neutrophil count >500/μL; Platelets ≥20,000/μL
Measured: 1 month
Secondary outcomes (1)
Disease Control Rate, DCR
(markedly effective + effective + stable disease) / number of patients × 100%
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion16 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced and Relapsed Solid TumorsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiang lu, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Investigators
- Xiang Lu, Professor, Principal investigator, The First People's Hospital of Nanninghuiqin Wei, Professor, Principal investigator, Minzu Hospital of Guangxi Zhuang Autonomous Regionyajing Huang, Professor, Principal investigator, Innovvy(Beijing) Biomedical Technology Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356856
- Sponsor's protocol ID
- MST-ST-02
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Microtransplantation for Advanced and Relapsed Solid Tumors
- ClinicalTrials.gov ID
- NCT07356856
- Acronym / sponsor ID
- MST-ST-02
- Conditions
- Advanced and Relapsed Solid Tumors
- Keywords
- microtransplantation, solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 16 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 21 Jan 2026 (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.
In this study, microtransplantation (MST) will be administrated to patients diagnosed with advanced / relapsed solid tumors to assess the therapeutic efficacy and safety of conventional chemotherapy in combination with MST for the treatment of advanced/relapsed solid tumors.
Detailed description
In this study, the eligible patients will receive MST treatment following conventional chemotherapy, MST is the infusion of G-PBMCs after chemotherapy. G-PBMCs are peripheral blood mononuclear cells from HLA mismatched unrelated donors mobilized by granulocyte colony-stimulating factor (G-CSF).
Based on the patient's medical history, current tumor assessment results, and the latest cancer treatment guidelines, an individualized chemotherapy plan for the patient is formulated through discussions among more than three oncologists. After each course of treatment, all relevant indicators, including efficacy and safety measures are evaluated.
Patients will receive all treatment for four courses, with an interval of 21 to 28 days. After completing all the treatment courses, the patient will enter the evaluation stage. Patients who have entered the evaluation stage are permitted to receive any treatments, including symptomatic support treatment, after the completion of treatment or withdrawal from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microtransplantation; MST | Experimental | Biological: MSTconventional chemotherapy with microtransplantation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are 18 to 90 years old, regardless of gender or race;
- Advanced / relapsed solid tumors (small cell lung cancer, ovarian cancer, cervical cancer, gastric and colorectal cancer, sarcoma, head and neck tumor, etc.) are confirmed by clinical or histopathological diagnosis;
- More than two kinds of tumors are allowed;
- Karnofsky score ≥ 40, ECoG physical status ≤ 3;
- There are measurable lesions;
Key exclusion criteria (3 listed)
- The researchers considered patients who were not suitable to participate in this experiment；
- Patients with mental disorders；
- Patients who refuse to cooperate with the treatment；
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 |
|---|---|---|
| MSTconventional chemotherapy with microtransplantation(MST). Microtransplantation, which is the infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood mononuclear cells (GPBMC) | Biological | microtransplantation; MST |
Primary outcome
Treatment-Emergent Adverse Events
Time frame: 1 month
Treatment related mortality
time of hematopoietic recovery
Time frame: 1 month
Absolute neutrophil count >500/μL; Platelets ≥20,000/μL
1 secondary outcome
Disease Control Rate, DCR
Time frame: 1 year
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 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Xiang Lu, Professor principal investigator
The First People's Hospital of Nanning
huiqin Wei, Professor principal investigator
Minzu Hospital of Guangxi Zhuang Autonomous Region
yajing Huang, Professor principal investigator
Innovvy(Beijing) Biomedical Technology Co., Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MST in people with Advanced and Relapsed Solid Tumors, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 3 sites 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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.
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 Xiang Lu, Professor (86-18077107296, 2584779171@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent Adverse Events (time frame: 1 month). The study lists 2 primary outcomes in all. 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 21 Jan 2026.