NCT07152236WithdrawnNot Applicable
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., Ltd1 site in 1 country20 target enrollmentStarted: August 31, 2025Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Evaluation of Safety
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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 Criteria
- •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.
Arms & Interventions
CAR-T
Experimental
The administration can be performed via intravenous infusion, either as a single dose or multiple doses, at a dosage ranging from 3×10⁶ to 1×10⁷ CAR-positive T cells per kilogram of body weight, with an allowable deviation of ±20%.
Intervention: CAR-T (Biological)
Outcomes
Primary Outcomes
Evaluation of Safety
Time Frame: Up to 1 years after CAR-T infusion
Count the Incidence of adverse events
Effectiveness evaluation
Time Frame: Up to 1 year after CAR-T infusion
According to the RECIST 1.1 evaluation criteria for the efficacy of solid tumors, the objective response rate (ORR) of all patients after CAR-T treatment, including complete response (CR) and partial response (PR).
Secondary Outcomes
- Pharmacokinetic parameters(Up to 1 year after CAR-T infusion)
- Pharmacodynamic parameters(Up to 1 year after CAR-T infusion)
Investigators
Study Sites (1)
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