Solid Tumors
Conditions
Keywords
Solid Tumors
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.
Interventions
BIOLOGICALCAR-T
Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.
Sponsors
Guangzhou Bio-gene Technology Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The patient fully understands the study procedures and voluntarily signs the informed consent form. 2. Patients diagnosed with tumors that demonstrate positive B7H3 expression in tumor tissues as confirmed by immunohistochemistry (IHC). 3. Presence of at least one extracranial lesion that is measurable according to the RECIST 1.1 criteria; 4. Estimated survival duration of ≥12 weeks; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1 at baseline; 6. Recovery from prior treatment-related toxicities to a level below Grade 2. 7. Adequate hematopoietic and organ function without severe impairment; 8. Availability of suitable venous access for leukapheresis, with no contraindications to the collection of white blood cells.
Exclusion criteria
1. Patients with a history of or currently diagnosed with other malignant tumors; 2. Presence of brain metastases or clinically significant central nervous system (CNS) disorders; 3. 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; 4. HIV+，HBV，HCV，EBV，CMV. 5. Positive T-cell interferon-gamma release assay or sputum smear for tuberculosis; 6. Documented history or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or significant pulmonary dysfunction; 7. History of severe allergic reactions or known hypersensitivity to any component of the investigational drugs used in the study; 8. Severe cardiovascular disease or uncontrolled refractory hypertension, unless deemed stable and non-interfering with the study by the investigator; 9. Severe hepatic or renal dysfunction, or presence of altered mental status; 10. Active autoimmune or inflammatory neurological disorders; 11. Presence of uncontrolled infections requiring systemic antibiotic, antifungal, or antiviral therapy; 12. Receipt of (attenuated) live vaccines within 4 weeks prior to screening; 13. Individuals with a history of alcohol dependence or substance abuse; 14. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Safety | Up to 1 years after CAR-T infusion | Count the Incidence of adverse events |
| Effectiveness evaluation | 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters | Up to 1 year after CAR-T infusion | The highest concentration of CAR-T cell expansion in peripheral blood after administration |
| Pharmacodynamic parameters | Up to 1 year after CAR-T infusion | The peak values of CAR-T-related cytokines, which include at least IL-6 and IFN-γ. |
Countries
China
Outcome results
None listed