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Construction of chimeric antigen receptor macrophages (CAR-M) and its application in immunotherapy for malignant tumor xenografts

Construction of chimeric antigen receptor macrophages (CAR-M) and its application in immunotherapy for malignant tumor xenografts

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097356
Enrollment
Unknown
Registered
2025-02-18
Start date
2022-11-18
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gliomas and brain metastases (breast/lung cancer)

Interventions

Gliomas and brain metastases (breast/lung cancer):none

Sponsors

The First Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Tumor patients: Prospective study sample Inclusion criteria: 1. Age 18–65 years, regardless of gender. 2. Cranial MRI examination, with at least one measurable target lesion =5 mm in size. 3. Estimated survival of >=3 months. 4. Karnofsky Performance Status (KPS) score >=60. 5. Written informed consent obtained from the participant, with willingness to comply with follow-up visits (cannot participate in multiple clinical studies simultaneously). Tumor patients: Retrospective study sample Inclusion criteria: 1. Age 18–65 years, regardless of gender. 2. Cranial MRI examination, with at least one measurable target lesion =5 mm in size. 3. Corresponding biospecimens available in the biobank. Healthy donors: Inclusion criteria 1. Age 18–55 years, regardless of gender. 2. Weight: >=50 kg for males, >=45 kg for females. 3. Blood pressure: Systolic pressure: >=12.0 kPa (90 mmHg) and =8.0 kPa (60 mmHg) and =30 mmHg/4.0 kPa 4. Pulse rate: 60–100 beats per minute; =50 beats per minute for highly endurance-trained athletes, with regular rhythm. 5. Body temperature: Normal. 6. General health status: a) No jaundice of the skin or sclera; no skin infections or extensive dermatological conditions. b) No severe or higher-level disabilities in the limbs; no significant functional impairments or joint swelling. c) No skin damage at the venous puncture sites on both arms; no signs of intravenous drug use.

Exclusion criteria

Exclusion criteria: Tumor patients: Prospective study sample Exclusion criteria: 1. Intracerebral hemorrhage confirmed by examination to be caused by other diseases such as cerebral aneurysm, brain tumor, traumatic brain injury, cerebral parasitic disease, cerebral vascular malformation, moyamoya disease, arteritis, hematologic disorders, or metabolic disorders. 2. Patients with a history of subarachnoid hemorrhage or ischemic stroke. 3. Platelet count 1.4, or abnormal coagulation function at admission. 4. Creatinine levels above the upper limit of normal. 5. Presence of any physical or psychiatric conditions that may affect the efficacy assessment of this study. Tumor patients: Retrospective study sample Exclusion criteria: 1. Intracerebral hemorrhage confirmed by examination to be caused by other diseases such as cerebral aneurysm, brain tumor, traumatic brain injury, cerebral parasitic disease, cerebral vascular malformation, moyamoya disease, arteritis, hematologic disorders, or metabolic disorders. 2. Patients with a history of subarachnoid hemorrhage or ischemic stroke. 3. Platelet count .4, or abnormal coagulation function at admission. 4. Creatinine levels above the upper limit of normal. 5. Presence of any physical or psychiatric conditions that may affect the efficacy assessment of this study. Healthy donors: Exclusion criteria 1. History of HIV/AIDS or infection with HIV, syphilis, gonorrhea, or other sexually transmitted diseases. 2. History of drug abuse, homosexuality, or multiple sexual partners. 3. History of hepatitis or positive hepatitis test results. 4. Women who are menstruating or within three days before or after menstruation, pregnant, breastfeeding, or within six months after an abortion. 5. History of heart disease, lung disease, kidney disease, liver disease, hematologic disorders, leprosy, tuberculosis, hyperthyroidism, diabetes, hypertension, hyperlipidemia, allergic diseases, dysentery, typhoid fever, or other diseases. 6. Other conditions that are not suitable for blood donation.

Design outcomes

Primary

MeasureTime frame
Tumor cell viability;

Secondary

MeasureTime frame
Multicolor fluorescent staining;Hematoxylin-eosin staining;

Countries

China

Contacts

Public ContactYu Shi

The First Affiliated Hospital of the Army Medical University

drshiyu@126.com+86 135 1235 0865

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026