Clinical Study on the Safety and Efficacy of B7H3 CAR T Cells in Patients With B7H3 Positive Solid Tumors
A Clinical Study Evaluating the Safety and Efficacy of B7H3 CAR-T Cell Therapy in Patients With B7H3-Positive Solid Tumors
Guangzhou Bio-gene Technology Co., Ltd
20 participants
Aug 31, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 ≥12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1 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.
Exclusion Criteria14
- 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;
- HIV+，HBV，HCV，EBV，CMV.
- Positive T-cell interferon-gamma release assay or sputum smear for tuberculosis;
- Documented 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 component of the investigational drugs used in the study;
- Severe cardiovascular disease or uncontrolled refractory hypertension, unless deemed stable and non-interfering with the study by the investigator;
- Severe hepatic or renal dysfunction, or presence of altered mental status;
- Active autoimmune or inflammatory neurological disorders;
- Presence of uncontrolled infections requiring systemic antibiotic, antifungal, or antiviral therapy;
- Receipt of (attenuated) live vaccines within 4 weeks prior to screening;
- Individuals with a history of alcohol dependence or substance abuse;
- Pregnant or lactating women.
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Interventions
Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07152236