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CAR T-cell Therapy
CAR-T Cell Therapy for Brain Cancer
Beijing, China
Phase 1
Recruiting
Led By Nan Ji, Dr.
Research Sponsored by Tcelltech Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
2. Male or female subjects aged 18 to 75 years (both inclusive).
3. 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. Subjects must have had experienced disease recurrence or progression\* after surgery combined with Stupp regimen (concurrent radiotherapy and temozolomide (TMZ) followed by adjuvant TMZ) and are not candidate for re-resection. For subjects harboring specific gene mutations, such as NTRK gene fusion or BRAF V600E mutation, they must have also progressed on corresponding mutation-directed therapies before enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment called anti-B7-H3 CAR-T cell injection for people with Grade 4 Glioma. The study will look at how safe and effective the treatment is and
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Who is the study for?
This trial is for adults aged 18-75 with Grade 4 Glioma, such as glioblastoma, that has come back or gotten worse after standard treatment. They must have B7-H3 positive tumors and be in a condition where they can perform daily activities to some extent (KPS score ≥60). Their heart should pump well (LVEF ≥40%) and they need good oxygen levels while resting.Check my eligibility
What is being tested?
The study tests TX103 CAR-T cell therapy's safety and effectiveness against aggressive brain cancer. It's an early-stage trial to find the highest dose patients can take without serious side effects and decide on the best dose for future studies.See study design
What are the potential side effects?
As this is a phase I trial primarily assessing safety, specific side effects are not listed but may include typical CAR-T related reactions like fever, fatigue, immune system complications, neurological events, and potential impact on normal blood cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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I have a grade 4 brain tumor and it has gotten worse after treatment.
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My cancer's return or worsening was confirmed by imaging or biopsy.
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My tumor shows high B7-H3 levels.
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I can care for myself but may not be able to do active work.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety：Incidence and severity of adverse events (AEs)
Safety：Incidence of Dose Limiting Toxicity (DLT)
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DOR)
Duration of disease control (DDC)
+7 moreOther study objectives
Area under the concentration versus time curve (AUC) of TX103 CAR-T cells
Incidence of Secondary Malignancies
Peak Concentration (Cmax) of TX103 CAR gene
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Safety Run-InExperimental Treatment1 Intervention
Single-dose administration of TX103 via intraventricular(ICV) or intracavitary (ICT) .
Group II: Cohort B Dual delivery route(Multi-dose)Experimental Treatment1 Intervention
Administration of TX103 on Day 1 via intracavitary (ICT) and on Day 8 via intraventricular(ICV) in a 21-day treatment cycle.
Group III: Cohort A Single delivery route(Multi-dose)Experimental Treatment1 Intervention
Administration of TX103 via intraventricular(ICV) on Days 1 and 8 in a 21-day treatment cycle.
Find a Location
Closest Location:Mayo Clinic in Rochester· Rochester, MN· 562 miles
Who is running the clinical trial?
Tcelltech Inc.Lead Sponsor
Beijing Tiantan HospitalOTHER
459 Previous Clinical Trials
11,099,053 Total Patients Enrolled
Mayo ClinicOTHER
3,416 Previous Clinical Trials
3,209,352 Total Patients Enrolled
Gangxiong Huang, MDStudy DirectorTcelltech Inc.
Nan Ji, Dr.Principal InvestigatorBeijing Tiantan Hospital
2 Previous Clinical Trials
41 Total Patients Enrolled