Clinical Study of QH104 Cell Injection for the Treatment of Meningeal Metastases of B7H3+ Solid Tumors

NCT06592092 | Completed

• 1 other identifier: QH10402-LMD-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, single-arm, single-center, interventional clinical study. It is planned to enroll 3-6 patients with meningeal metastases from B7H3+ solid tumors and to explore, on a small scale, the efficacy of local injection of allogeneic B7H3 CAR-γδ T cells (3\*107/dose) for the treatment of patients with meningeal metastases from B7H3+ solid tumors.

Conditions

Solid Tumor; Meningeal Metastasis

Keywords

B7H3 positive；; CAR-γδT cell

Outcome Measures

Primary Outcomes (1)

• Clinical response

  Evaluate the clinical response of QH104 cell injection in treating B7H3+ solid tumor meningeal metastases according to the Response Assessment in Neuro-Oncology (RANO) criteria

  day14

Secondary Outcomes (5)

• Overall survival(OS)

  3month,6month,12month

• Incidence of Adverse Events (AEs)

  day14 and day 28

• quality of life(QoL) score

  day 14 and day 28

• Pharmacokinetic (PK)

  At days 0, 1, 3, 7, and 14

• Pharmacodynamic (PD)

  At days 0, 1, 3, 7, and 14

Study Arms (1)

QH104 cell Injection(Allogenic B7H3 CAR-γδT cell)

EXPERIMENTAL

Plan to enroll 3 to 6 patients with meningeal metastasis of B7H3+ solid tumor with single or multiple local injections of allogenic B7H3 CAR-γδ T cells (3\*107/ dose)

Biological: QH104 Cell injection

Interventions

QH104 Cell injection BIOLOGICAL

Patients will first be pre-screened for B7H3 expression of tumor and exist Meningeal Metastases.

QH104 cell Injection(Allogenic B7H3 CAR-γδT cell)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Have a histologically or cytologically confirmed solid malignant tumor with positive B7H3 expression;
• ECOG ≤ 2 or KPS ≥ 60;
• Life expectancy ≥ 8 weeks as assessed by the investigator;
• Meningeal metastases (or with brain parenchymal metastases) from any solid malignancy that is refractory to standard treatment or for which no standard treatment is available and positive cerebrospinal fluid (CSF) cytology;
• Substantially normal bone marrow reserve function and normal hepatic and renal function (laboratory tests are required to be satisfied prior to first treatment with QH104 Cell Injection):
• White blood cell count (WBC) ≥ 3 x 109/L; Lymphocyte count (LY) ≥ 0.8 x 109/L; Hemoglobin (Hb) ≥ 90 g/L; Platelet (PLT) ≥90×109/L; Albumin transaminase (ALT) \& albumin transaminase (AST) \< 1.5 x ULN; Serum creatinine (Cr) \< 1.5 x ULN; Total bilirubin \< 1.5 x ULN; PT \& PTT ≤ 1.25 × ULN.
• Pregnancy test should be negative for women of childbearing potential and both men and women agree to use effective contraception during treatment and for 1 year thereafter;
• Be able to understand the requirements and matters of the trial and be willing to participate in the clinical study as required;
• Sign the trial informed consent form.

You may not qualify if:

• Targeted CNS irradiation within 7 days prior to receiving the first QH104 infusion;
• Uncontrolled comorbidities including, but not limited to: persistent or active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or psychiatric/social conditions that would limit the patient's ability to comply with study requirements;
• Has a known psychiatric or substance abuse disorder that would interfere with cooperation with trial requirements;
• Is receiving treatment with any other investigational drug;
• Have a confirmed diagnosis of an immunodeficiency disorder;
• Have an active infection requiring systemic treatment;
• Inability to perform an MRI;
• Serious cardiovascular compromise: history of New York Heart Association (NYHA) class II or greater congestive heart failure, unstable angina, myocardial infarction or stroke within 6 months of first dose, or arrhythmia requiring treatment at screening;
• Allergy to immunotherapy and related cells;
• Prior treatment with CAR-T and other immune cell therapy;
• Other reasons, in the opinion of the investigator, why participation in this study is not appropriate.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Meningeal Carcinomatosis

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Ning Li, Ph.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: September 19, 2024
• Study Start: April 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: January 28, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (1)