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New treatment option for Recurrent Glioblastoma
Official title Tris-CAR-T Cell Therapy for Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT05577091
What this study is testing
What is Inverse correlated dual-target, truncated IL7Ra modified CAR -expressing autologous T-lymphocytes.?
Inverse correlated dual-target, truncated IL7Ra modified CAR -expressing autologous T-lymphocytes. is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for recurrent glioblastoma.
Also referred to as Autologous Tris-CAR-T cell..
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 1 study of recurrent glioblastoma locoregional adoptive therapy with autologous peripheral blood T cells lentivirally transduced to express a dual-target, truncated IL7Ra modified chimeric antigen receptor (CAR), delivered by Ommaya reservoir, a pre-indwelled catheter in the tumor resection cavity or ventricle. Patients with pathological confirmation of glioblastoma and radiological evidence of recurrence are candidates for this clinical trial.
- Phase 1: an early, usually small safety study
- Time commitment: about 8 weeks
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 70
You may be able to join if
- Age: 18 years to 70 years (including cut-off values).
- Patients with history of glioblastoma are diagnosed with recurrent glioblastoma and residual tumor after intracranial tumor resection/biopsy...
- Patients who finished radiotherapy or temozolomide/bevacizumab or other drugs for at least 4 weeks. All toxicities of prior treatment should be...
- Patients who is suitable for craniotocerebrospinal fluid shunt and attachment (Ommaya device) implantation confirmed by a competent physician.
- Patients and/or legal representative is able to sign written informed consent.
You likely can't join if
- Kanovsky Performance Status (KPS) ≤ 70.
- Highly allergic constitution or severe allergies history.
- Those who have psychiatric or psychological diseases and cannot cooperate with treatment and how well it works assessment.
- Receive other drug trials within 60 days before enrollment, or receive other routine treatment in non-experimental designs for glioblastoma, such as...
- Combined with infection, active infection, fever of unknown cause.
- Combined with serious or unstable heart, lung, liver, kidney and hematopoietic system diseases, including active hepatitis.
See the full eligibility criteria
- Age: 18 years to 70 years (including cut-off values).
- Patients with history of glioblastoma are diagnosed with recurrent glioblastoma and residual tumor after intracranial tumor resection/biopsy performed in Beijing Tiantan Hospital.
- Patients who finished radiotherapy or temozolomide/bevacizumab or other drugs for at least 4 weeks. All toxicities of prior treatment should be defined as less than or equal to grade 1 (except for toxicities such as...
- Patients who is suitable for craniotocerebrospinal fluid shunt and attachment (Ommaya device) implantation confirmed by a competent physician.
- Patients and/or legal representative is able to sign written informed consent.
- Kanovsky Performance Status (KPS) ≥ 70.
- According to the researchers' judgment, the life expectancy ≥ 8 weeks.
- White blood cells (WBC) \> 3.50×10\^9/L (performed within 14 days prior to PBMC collection unless otherwise noted).
- Platelet ≥ 200×10\^9/L (performed within 14 days prior to PBMC collection unless otherwise noted).
- Hemoglobin ≥ 120 g/L (performed within 14 days prior to PBMC collection unless otherwise noted).
- Total bilirubin ≤ 20 μmol/L (performed within 14 days prior to PBMC collection unless otherwise noted).
- Aspartic acid aminotransferase (AST) ≤ 2.5×42 U/L (performed within 14 days prior to PBMC collection unless otherwise noted).
- Alanine aminotransferase (ALT) ≤ 2.5×41 U/L (performed within 14 days prior to PBMC collection unless otherwise noted).
- Serum creatinine ≤ 90 μmol/L (performed within 14 days prior to PBMC collection unless otherwise noted).
- Blood oxygen saturation ≥ 95% (performed within 14 days prior to PBMC collection unless otherwise noted).
- Seronegative of the combination of human immunodeficiency virus (HIV) antibody (Ab) (performed within 14 days prior to PBMC collection unless otherwise noted).
- Fertile women: a negative serum pregnancy test (performed within 14 days prior to PBMC collection unless otherwise noted).
- The patient agrees that contraception should be used in patients of childbearing age for at least 3 months from screening to the last infusion of Tris-CAR-T cells. The period of childbearing age is defined as...
- Kanovsky Performance Status (KPS) ≤ 70.
- Highly allergic constitution or severe allergies history.
- Those who have psychiatric or psychological diseases and cannot cooperate with treatment and how well it works assessment.
- Receive other drug trials within 60 days before enrollment, or receive other routine treatment in non-experimental designs for glioblastoma, such as stereotactic radiation therapy or placement of carmustine wafers.
- Combined with infection, active infection, fever of unknown cause.
- Combined with serious or unstable heart, lung, liver, kidney and hematopoietic system diseases, including active hepatitis.
- Combined with inflammation and immune system diseases (such as rheumatoid arthritis), or known immunosuppressive diseases.
- Combined with neurological diseases, such as diffuse leptomeningeal disease, or neurodegenerative diseases.
- Known allergies to immunotherapy and related cellular products.
- Patients who have received any gene therapy before.
- Long-term use of immunosuppressants is required for any reason.
- Patients with a history of organ transplantation or who are waiting for organ transplantation.
- Special cases: pregnancy or lactation.
- Other circumstances in which the investigators believe the patient is unsuitable for this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.