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

NCT07152236 | Recruiting

• 1 other identifier: CF-25-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Evaluation of Safety

  Count the Incidence of adverse events

  Up to 1 years after CAR-T infusion

• Effectiveness evaluation

  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).

  Up to 1 year after CAR-T infusion

Secondary Outcomes (2)

• Pharmacokinetic parameters

  Up to 1 year after CAR-T infusion

• Pharmacodynamic parameters

  Up to 1 year after CAR-T infusion

Study Arms (1)

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%.

Biological: CAR-T

Interventions

CAR-T BIOLOGICAL

Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.

CAR-T

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Bio-gene Technology Co., Ltd: lead

Study Sites (1)

Dongguan Taixin Hospital

Dongguan, Guangdong, 523125, China

RECRUITING

Central Study Contacts

Chaoke Bu, Doctor

CONTACT

+86 18028678752; 15312577@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)