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Trial Title:
Clinical Study of QH104 Cell Injection for the Treatment of Meningeal Metastases of B7H3+ Solid Tumors
NCT ID:
NCT06592092
Condition:
Solid Tumor
Meningeal Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Meningeal Carcinomatosis
Conditions: Keywords:
B7H3 positive；
CAR-γδT cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
QH104 Cell injection
Description:
Patients will first be pre-screened for B7H3 expression of tumor and exist Meningeal
Metastases.
Arm group label:
QH104 cell Injection(Allogenic B7H3 CAR-γδT cell)
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.
Detailed description:
This study 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 clinical response to local injection of allogeneic B7H3
CAR-γδ T cells (3*107/dose) for the treatment of patients with meningeal metastases from
B7H3+ solid tumors. During the period of cell therapy, the enrolled subjects may be given
additional multiple infusions of cells, after imaging, neurological function,
cerebrospinal fluid cytology or the investigator's assessment of the potential benefit of
continuing cell therapy. It is recommended that the frequency of multiple infusions be 2
weeks each, and the interval between infusions can be adjusted at a later stage based on
the PK and clinical symptoms of the subject after infusion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years;
2. Have a histologically or cytologically confirmed solid malignant tumor with positive
B7H3 expression;
3. ECOG ≤ 2 or KPS ≥ 60;
4. Life expectancy ≥ 8 weeks as assessed by the investigator;
5. 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;
6. 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.
7. 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;
8. Be able to understand the requirements and matters of the trial and be willing to
participate in the clinical study as required;
9. Sign the trial informed consent form.
Exclusion Criteria:
1. Targeted CNS irradiation within 7 days prior to receiving the first QH104 infusion;
2. 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;
3. Has a known psychiatric or substance abuse disorder that would interfere with
cooperation with trial requirements;
4. Is receiving treatment with any other investigational drug;
5. Have a confirmed diagnosis of an immunodeficiency disorder;
6. Have an active infection requiring systemic treatment;
7. Inability to perform an MRI;
8. 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;
9. Allergy to immunotherapy and related cells;
10. Prior treatment with CAR-T and other immune cell therapy;
11. Other reasons, in the opinion of the investigator, why participation in this study
is not appropriate.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Ning Li, Ph.D
Phone:
010-87788713
Email:
lining@cicams.ac.cn
Contact backup:
Last name:
Shuhang Wang, Ph.D
Phone:
+8613581809307
Email:
cancergcp@163.com
Contact backup:
Last name:
Ning Li, Ph.D
Facility:
Name:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Start date:
April 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06592092
