Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT07164560
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploratory Study of TRBC1/2-Targeted CAR-T Cell Therapy in Relapsed/Refractory Peripheral T-Cell Lymphoma
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
Clinical Study of TRBC1/2-Targeted CAR-T Cells in the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-08
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 study aims to evaluate the safety and efficacy of TRBC1/2-directed chimeric antigen receptor T cells (TRBC1/2 CAR-T cells) in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL).
Detailed Description:
This is a multicenter, open-label, single-arm, phase I clinical trial designed to evaluate the safety and efficacy of TRBC1/2 CAR-T cell therapy in patients with TRBC1/2-positive T-cell lymphoma.
The study will be conducted in two parts:
Phase I (Dose Escalation):
A dose-escalation study will be carried out following the conventional "3+3" design, with one dose level administered via intravenous infusion. Each cohort will enroll 3 to 6 patients. After the initial infusion, patients will be observed for at least 28 days for safety evaluation, followed by long-term follow-up of up to 2 years post-infusion.
Phase II (Dose Expansion):
Based on safety, in vivo expansion and persistence of TRBC1/2 CAR-T cells, and preliminary efficacy results from Phase I, the recommended dose and administration schedule will be determined. Approximately 30 eligible patients will then be enrolled to further assess safety and efficacy at the selected dose. Following the first infusion of TRBC1/2 CAR-T cells, patients will continue in long-term follow-up for up to 2 years.
The study will be conducted in two parts:
Phase I (Dose Escalation):
A dose-escalation study will be carried out following the conventional "3+3" design, with one dose level administered via intravenous infusion. Each cohort will enroll 3 to 6 patients. After the initial infusion, patients will be observed for at least 28 days for safety evaluation, followed by long-term follow-up of up to 2 years post-infusion.
Phase II (Dose Expansion):
Based on safety, in vivo expansion and persistence of TRBC1/2 CAR-T cells, and preliminary efficacy results from Phase I, the recommended dose and administration schedule will be determined. Approximately 30 eligible patients will then be enrolled to further assess safety and efficacy at the selected dose. Following the first infusion of TRBC1/2 CAR-T cells, patients will continue in long-term follow-up for up to 2 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: