Efficacy and Safety of Microtransplantation for Advanced and Relapsed Solid Tumors

January 13, 2026 updated by: xiang lu, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Haidian, Beijing Municipality, China
        • Innovvy(Beijing) Biomedical Technology Co., Ltd
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • The First People's Hospital of Nanning
        • Contact:
        • Principal Investigator:
          • Xiang Lu, Professor
      • Nanning, Guangxi, China
        • Minzu Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
          • huiqin Wei, Professor
          • Phone Number: 86-13978676174
          • Email: 99415185@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: microtransplantation; MST
conventional chemotherapy with microtransplantation
Biological: MST
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-Emergent Adverse Events
Time Frame: 1 month
Treatment related mortality
1 month
time of hematopoietic recovery
Time Frame: 1 month
Absolute neutrophil count >500/μL; Platelets ≥20,000/μL
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate, DCR
Time Frame: 1 year
(markedly effective + effective + stable disease) / number of patients × 100%
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Xiang Lu, Professor, The First People's Hospital of Nanning
  • Principal Investigator: huiqin Wei, Professor, Minzu Hospital of Guangxi Zhuang Autonomous Region
  • Principal Investigator: yajing Huang, Professor, Innovvy(Beijing) Biomedical Technology Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

January 16, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MST-ST-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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