Actively Recruiting
Clinical Study on the Safety and Efficacy of B7H3 CAR T Cells in Patients With B7H3 Positive Solid Tumors
Led by Guangzhou Bio-gene Technology Co., Ltd · Updated on 2025-09-03
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-arm, single-center investigator-initiated trial (IIT) evaluates the safety, efficacy, and pharmacodynamic (PD)/pharmacokinetic (PK) profiles of CAR-T cells in patients with advanced solid tumors. Eligible subjects are followed until 12 months after infusion or until meeting treatment withdrawal criteria, whichever occurs first.
CONDITIONS
Official Title
Clinical Study on the Safety and Efficacy of B7H3 CAR T Cells in Patients With B7H3 Positive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient fully understands the study procedures and voluntarily signs the informed consent form.
- Patients diagnosed with tumors that demonstrate positive B7H3 expression in tumor tissues as confirmed by immunohistochemistry (IHC).
- Presence of at least one extracranial lesion that is measurable according to the RECIST 1.1 criteria.
- Estimated survival duration of 612 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 41 at baseline.
- Recovery from prior treatment-related toxicities to a level below Grade 2.
- Adequate hematopoietic and organ function without severe impairment.
- Availability of suitable venous access for leukapheresis, with no contraindications to the collection of white blood cells.
You will not qualify if you...
- Patients with a history of or currently diagnosed with other malignant tumors.
- Presence of brain metastases or clinically significant central nervous system (CNS) disorders.
- Prior treatment within 14 days or five half-lives (whichever is longer) before blood collection for CAR-T preparation that may interfere with lymphocyte expansion.
- Positive for HIV, HBV, HCV, EBV, or CMV infections.
- Positive T-cell interferon-gamma release assay or sputum smear for tuberculosis.
- History or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or significant pulmonary dysfunction.
- History of severe allergic reactions or known hypersensitivity to any study drug component.
- Severe cardiovascular disease or uncontrolled refractory hypertension unless stable and non-interfering.
- Severe liver or kidney dysfunction, or altered mental status.
- Active autoimmune or inflammatory neurological disorders.
- Presence of uncontrolled infections requiring systemic antibiotic, antifungal, or antiviral therapy.
- Receipt of live attenuated vaccines within 4 weeks prior to screening.
- History of alcohol dependence or substance abuse.
- Pregnant or lactating women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dongguan Taixin Hospital
Dongguan, Guangdong, China, 523125
Actively Recruiting
Research Team
C
Chaoke Bu, Doctor
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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