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NCT Number: NCT07356856

Efficacy and Safety of Microtransplantation for Advanced and Relapsed Solid Tumors

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Innovvy(Beijing) Biomedical Technology Co., Ltd, Haidian, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

MST

Biological

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)

Primary outcomes

  1. Treatment-Emergent Adverse Events

    Time frame: 1 month

    Treatment related mortality

  2. time of hematopoietic recovery

    Time frame: 1 month

    Absolute neutrophil count >500/μL; Platelets ≥20,000/μL

Secondary outcomes

  1. Disease Control Rate, DCR

    Time frame: 1 year

    (markedly effective + effective + stable disease) / number of patients × 100%

Study contacts

Contact information is provided by the study sponsor or research team.

Xiang Lu, Professor

CONTACT

[email protected]

86-18077107296

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.