Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 4:13 AM
Study NCT ID:
NCT07369492
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma
Sponsor:
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2026-02
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:
The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.
Detailed Description:
This is a prospective open-label, single-arm clinical study to evaluate the safety, tolerability of BAFF-R CAR-T cells in adult subjects with CD19-negative relapsed or refractory B-Cell Lymphoma. The study plans to explore across three dose levels (1.00 × 10\^6, 3.00 × 10\^6, 9.00 × 10\^6 CAR+ T cells/kg), and 6.00×10\^8 CAR+T cells as maximum dose, aiming to evaluate the safety, tolerability of BAFF-R CAR-T cells in CD19-negative relapsed or refractory B-Cell Lymphoma, explore Maximum Tolerated Dose (MTD) and determine the recommended dose for Phase II. Besides, efficacy, pharmacokinetics and persistence profile of CAR-T cells are also study objectives.
Study Oversight
Has Oversight DMC:
None
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?: