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CAR-Macrophage Injection for Advanced Solid Tumors Expressing Specific Antigens

Study Aim

This early phase 1 study aims to determine the optimal dosing regimen and evaluate the safety, by observing the incidence of adverse events and dose-limiting toxicities, of CAR-Macrophage injection in patients with advanced solid tumors expressing specific antigens.

What is being tested

CAR-M

Biological

Who is being recruted

From 18 to 75 Years

+38 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Early Phase 1

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Study ContactNing Li

Last updated: February 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 31, 2026

Actual date on which the first participant was enrolled.

This study is a phase 1 clinical trial, focusing on a new treatment approach for advanced solid tumors using CAR-Macrophages (CAR-M). The main goal is to evaluate the safety, tolerability, and preliminary anti-tumor activity of CAR-M injections in patients. This treatment targets specific antigens, such as HER2, PSMA, and FAP, which are often associated with various types of cancer. The importance of this study lies in its potential to provide a new therapeutic option for patients with advanced solid tumors, improving their care and addressing current challenges. The trial is designed to enroll patients based on strict criteria, including target antigen detection and indication confirmation. Participants will receive the CAR-M injection, with the dose gradually increasing according to a pre-set plan. This process helps to determine the safe dose range and pharmacokinetic characteristics of the treatment. The study measures the results by evaluating the incidence of adverse events and dose-limiting toxicities. It also aims to determine the optimal dosing regimen, balancing safety and anti-tumor activity, which may vary between a full dose and a split dose depending on the patient's baseline status and indications.

Official TitleA Phase I Platform Study of Target-Based Screened CAR-Macrophages for the Treatment of Advanced Malignant Tumors

NCT07409766

Principal SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Study ContactNing Li

Last updated: February 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

11 inclusion criteria required to participate

Electrolytes: Corrected calcium, potassium, and magnesium levels within the normal range.

Histologically or cytologically confirmed advanced solid tumor (partial laboratory test results are acceptable): HER2-positive: IHC 3+ or IHC 2+ with ISH+ PSMA+++: Intensity score 2+ with proportion ≥ 30%, or intensity score 3+ with proportion ≥ 10% FAP+++: Intensity score 2+ with proportion ≥ 30%, or intensity score 3+ with proportion ≥ 10%

Aged 18 to 75 years (inclusive) at the time of signing the informed consent form, with no gender restriction.

Disease status: Subjects (HER2-targeted): Patients with advanced solid tumor who are refractory to or intolerant of DS-8201 treatment. Subjects (PSMA-targeted): Patients with advanced solid tumor who are refractory to or intolerant of first- or second-line treatment. Subjects (FAP-targeted): Patients with advanced solid tumor who are refractory to or intolerant of first- or second-line treatment.

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27 exclusion criteria prevent from participating

Malignant neoplasms with a favorable prognosis (e.g., papillary thyroid carcinoma, carcinoma in situ of the skin or breast), regardless of whether they have been cured or not.

Central nervous system (CNS) disorders: epilepsy, stroke, dementia, or autoimmune diseases involving the CNS.

Known hypersensitivity to CAR-M or any of its excipients.

History of severe hypersensitivity to filgrastim (G-CSF) or tocilizumab.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Total dose: 5.0×10⁹ cells Day 1: 50% of the total dose Day 7: The remaining 50% of the dose \[only if no ≥Grade 2 chronic kidney syndrome/nephrotoxicity is observed after the first dose\]

Group II

Experimental

Total dose: 5.0×10⁹ cells Day 1: Full dose

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, ChinaOpen National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences in Google Maps

Recruiting soonOne Study Center