Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-15
Brief Title:
Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma
Sponsor:
Tcelltech Inc
Organization:
Tcelltech Inc
Study Overview
Official Title:
A Phase I Open-Label SingleMultiple Dose Dose-escalation Study to Evaluate the Safety Tolerability and Antitumor Activity of TX103 CAR-T Cell Injection TX103 in Subjects With Recurrent or Progressive Grade 4 Glioma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase I open-Label singlemultiple 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 GliomaThe study also plan to explore the Maximum Tolerated Dose MTD and determine the Recommended Phase II Dose RP2D of the CAR-T cell therapy
Detailed Description:
Eligible subjects will be enrolled into two sequential dose-escalating cohorts ie A and B and will be administrated TX103 Cohort A will receive TX103 exclusively through intraventricular ICV delivery while cohort B will undergo dual intracavitary ICT and ICV delivery Patients in each individual cohort will receive two TX103 infusions on Day 1 and 8 respectively followed by a 14-day observation period in a 21-day treatment cycle
Three escalating dosage levels are planned for each cohort Both Cohorts A and B will adopt the traditional 33 dose escalation design with each dose level enrolled with 3 to 6 patients The starting dose will be 6 107 CAR T cells ie Dose Level 1 DL1 Dose limiting toxicities DLTs will be assessed during the first cycle
Three escalating dosage levels are planned for each cohort Both Cohorts A and B will adopt the traditional 33 dose escalation design with each dose level enrolled with 3 to 6 patients The starting dose will be 6 107 CAR T cells ie Dose Level 1 DL1 Dose limiting toxicities DLTs will be assessed during the first cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None