Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05871684
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2023-05-09
Brief Title:
A Combination Study of CAR-T Therapy in rr B-NHL
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
A Phase II Study of BTKiRadiotherapyChemotherapy Bridging Before Chimeric Antigen Receptor T-cell Immunotherapy CAR-T in Combination With BTKiPD-1 Inhibitor Maintenance Therapy for RelapsedRefractory B-cell Non-Hodgkins Lymphoma rr B-NHL
Status:
RECRUITING
Status Verified Date:
2023-07
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:
In registry studies of CAR-T products that have been marketed globally patients with relapsed or refractory B-cell non-Hodgkins lymphoma rr B-NHL have been enrolled to receive CAR-T infusion in combination with tyrosine kinase inhibitors BTKi or immune checkpoint inhibitors PD-1 or PD-L1 antibodies with objective remission rate ORR for CAR-T in combination with BTKi ranging from 833-100 and complete remission rate CRR were 333-75 The ORRs for objective remission rates for CAR-T combined with PD1PD-L1 ranged from 50-91 and CRRs were 333-64 respectively With regard to safety no dose-limiting toxic DLT occurred and the incidence of other adverse reactions was low and studies demonstrated that BTKi or PD-1PD-L1 antibodies could further enhance the responsiveness and durability of anti-CD19 CAR-T cell therapy However there are no studies exploring the efficacy and safety of clinical regimens using BTKi radiotherapy chemotherapy as a bridging regimen to treat rr B-NHL in combination with BTKi andor PD-1 inhibitor after CAR-T cell infusion In real-world applications of commercial CAR-T CAR-T therapy combined with BTKi or PD-1PD-L1 antibodies may further improve response rates and remission persistence in rr B-NHL patients receiving CAR-T infusion back with efficacy benefits while ensuring a manageable safety profile Therefore our center plans to conduct a phase II clinical study of Regent CAR-T 001A phase II study of BTKiradiotherapychemotherapy bridging before CAR-T cell therpay in combination with BTKiPD-1 inhibitor for rr B-NHL
Detailed Description:
None
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?:
None