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Tests treatment safety and results for High-grade Glioma
Official title Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.
ClinicalTrials.gov ID: NCT06482905
What this study is testing
What is Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103?
Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high-grade glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people must voluntarily participate in the study and sign a written informed consent document; people should be willing and able to follow and...
- Male or female people aged 18 to 75 years (both inclusive).
- Subject must have histologically diagnosed grade 4 glioma, such as glioblastoma, grade 4 astrocytoma, diffuse hemispheric glioma, according to 2021...
- people with confirmed B7-H3 positive\ (≥30%) tumor expression by immunohistochemistry (IHC) in either primary or recurrent tumor tissue. \ B7-H3...
- people with KPS score of ≥60.
You likely can't join if
- Pregnant or breastfeeding female people.
- people with viral infection during the screening period:
- Serum HIV antibody positive, treponema pallidum serology positive; OR
- Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV DNA test value exceeds the normal range; OR
- Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive.
- Medical history and concomitant diseases:
See the full eligibility criteria
- people must voluntarily participate in the study and sign a written informed consent document; people should be willing and able to follow and complete study procedures.
- Male or female people aged 18 to 75 years (both inclusive).
- Subject must have histologically diagnosed grade 4 glioma, such as glioblastoma, grade 4 astrocytoma, diffuse hemispheric glioma, according to 2021 WHO Classification of Tumors of the CNS. people must have had...
- people with confirmed B7-H3 positive\ (≥30%) tumor expression by immunohistochemistry (IHC) in either primary or recurrent tumor tissue. \ B7-H3 positive rate is defined as the percentage of B7-H3 positive tumor cells...
- people with KPS score of ≥60.
- people should have adequate venous access for collection of peripheral blood mononuclear cells (PBMCs).
- people with left ventricular ejection fraction (LVEF) ≥ 40% within one month prior to the first dose.
- people with oxygen saturation ≥95% under the resting state.
- people with adequate organ function, as indicated by laboratory test results that meet the following criteria:
- Hematological function: Absolute neutrophil count (ANC) ≥1.5×109/L, hemoglobin (Hb) ≥90g/L, platelet count (PLT) ≥100×109/L, absolute lymphocytes count (ALC) ≥0.15×109/L. Blood transfusion, granulocyte (macrophage)...
- Liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN, patients with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, presenting as unconjugated bilirubin in the absence of evidence of hemolysis or liver...
- Renal function: serum creatinine (Scr) ≤1.5×ULN.
- Coagulation function (in the absence of anticoagulant therapy): prothrombin time (PT) or activated partial thromboplastin time (APTT) or international normalized ratio (INR) ≤ 1.5×ULN.
- Female people of childbearing potential must have a negative serum pregnancy test at screening and if a positive urine test or a negative result cannot be confirmed by urine test.
- Women of childbearing potential (which refer to women who have not been surgically sterilized and pre-menopausal women) should use highly effective and reliable method of contraception (refer to Section 5.3 for...
- Pregnant or breastfeeding female people.
- people with viral infection during the screening period:
- Serum HIV antibody positive, treponema pallidum serology positive; OR
- Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV DNA test value exceeds the normal range; OR
- Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive.
- Medical history and concomitant diseases:
- people who have received carmustine extended-release implantation surgery within 6 months;
- people with known or suspected active autoimmune diseases, including but not limited to Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.;
- people who are receiving systemic immunosuppressive agents or people who need to use immunosuppressive agents for a long-time during treatment, except for intermittent topical, inhaled, or intranasal glucocorticoid...
- people with uncontrolled mental disorders, or who, in the Investigator's opinion, have a medical history or a history of mental states that may increase the risks associated with study participation or study drug...
- The toxicity and side effects caused by previous treatment have not recovered to ≤ grade 1 (per CTCAE 5.0); except for alopecia and other tolerable events judged by the Investigator;
- people who have participated in other treatment clinical studies within the past 1 month;
- people who have previously received CAR-T cell therapy or other gene therapy\ ;
- people with any serious or poorly controlled disease that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or affect the subject's ability to...
- people with other malignant tumors in the past 3 years or at present, except for non-melanoma skin cancer, carcinoma in situ (such as cervix, bladder and breast cancer).
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States; Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.