B7H3-directed CAR T cell therapy for 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

This will test B7H3-targeted CAR T cells in people with advanced B7H3-positive solid tumors to see if the treatment is safe and can shrink tumors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 1 Year to 75 Years
• Sex: All
• Sponsor: Guangzhou Bio-gene Technology Co., Ltd (Industry-sponsored)
• Drugs / interventions: CAR-T, radiation
• Locations: 1 site (Dongguan, Guangdong)
• Trial ID: NCT07152236 on ClinicalTrials.gov

What this trial studies

This single-arm, single-center investigator-initiated trial delivers autologous CAR T cells engineered to target B7H3 in patients whose tumor tissue is B7H3-positive by IHC. Eligible participants undergo leukapheresis for CAR T manufacture followed by infusion and close monitoring for safety, pharmacokinetics, and pharmacodynamics. The study uses RECIST 1.1 to document tumor responses and follows patients for up to 12 months after infusion or until withdrawal. Key eligibility includes measurable extracranial disease, ECOG 0–1, adequate organ function, and no active brain metastases.

Who should consider this trial

Good fit: Adults with advanced extracranial solid tumors that test positive for B7H3 by immunohistochemistry, have at least one measurable lesion, ECOG performance status 0–1, adequate organ and marrow function, and suitable venous access for leukapheresis.

Not a fit: Patients with brain metastases or significant CNS disorders, another active malignancy, poor performance status, or inadequate organ function are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, this therapy could offer a new targeted cell therapy option that reduces tumor burden and potentially extends survival for patients with B7H3-positive solid tumors.

How similar studies have performed: CAR T cell therapies have produced major successes in hematologic cancers but have shown limited clinical success in solid tumors so far, and B7H3-directed CAR T is an emerging approach supported mainly by preclinical work and early-phase clinical efforts.

Eligibility criteria

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.

Where this trial is running

Dongguan, Guangdong

• Dongguan Taixin Hospital — Dongguan, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Chaoke Bu, Doctor

Conditions Solid Tumors