Actively Recruiting
Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors
Led by UTC Therapeutics Inc. · Updated on 2026-03-19
30
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
U
UTC Therapeutics Inc.
Lead Sponsor
T
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-HER2 CAR-T cell injection in patients with HER2-positive advanced malignant solid tumors.
CONDITIONS
Official Title
Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years inclusive
- Histologically confirmed malignant solid tumors refractory to or relapsing after standard therapy
- At least one measurable tumor lesion according to RECIST v1.1
- HER2-positive status confirmed by Immunohistochemistry in tumor tissue
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Organ function meets protocol requirements
- Female participants of childbearing potential must have a negative pregnancy test
- Participants (female of childbearing potential and male with partners of childbearing potential) must agree to use effective contraception from screening through 1 year after infusion
- Ability to understand the protocol, provide informed consent, and comply with study procedures
You will not qualify if you...
- Pregnant or lactating women
- Positive for hepatitis B surface antigen or active hepatitis B, hepatitis C, HIV, or syphilis infection
- Unresolved toxicities from prior therapies greater than grade 1 except hair loss and peripheral sensory nerve disorders
- History of any allogeneic tissue or organ transplantation requiring immunosuppressive therapy
- Prior treatment with anti-HER2 CAR-T cell therapy
- Major surgery or severe trauma within 4 weeks before consent or planned major surgery within 12 weeks after cell therapy
- Presence of symptomatic or unstable central nervous system metastases
- Clinically significant systemic disease affecting treatment tolerance or risk
- History of severe allergic reactions to study drugs or ingredients
- Received attenuated vaccine within 4 weeks prior to consent
- Participation in other clinical trials within 4 weeks prior to consent
- History of another malignancy within past 5 years except certain treated cancers
- History of neuropsychiatric diseases such as epilepsy, schizophrenia, dementia, or substance addiction
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Y
Yi Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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