Clinical Study on the Safety and Efficacy of B7H3 CAR T Cells in Patients With B7H3 Positive Solid Tumors

Guangzhou Bio-gene Technology

Status: Enrolling

Conditions: Solid Tumors

Treatments: Biological: CAR-T

Study type: Interventional

Funder types: Industry

Identifiers

NCT07152236

CF-25-004

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CAR-T

Experimental group

Description:

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%.

Treatment:

Biological: CAR-T