Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446128
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-16
Brief Title:
A Dose Escalating Study of CD19CD22BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin LymphomaNHL
Sponsor:
Shanghai Cell Therapy Group CoLtd
Organization:
Shanghai Cell Therapy Group CoLtd
Study Overview
Official Title:
A Dose Escalating Study of CD19CD22BCMA Three Targets Autologous Chimeric Antigen Receptor T CAR-T Cell Therapy in Subjects With Relapsed or Refractory B Cell Non-Hodgkin LymphomaNHL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 single arm open-label dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T CAR-T cells targeting CD19CD22BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma
Detailed Description:
This is a single arm open-label dose escalation investigator initiated IIT study the primary objective is to evaluate the safety and tolerability of CD19CD22BCMA CAR-T therapy in patients with B cell non-Hodgkin lymphoma and determine the maximum tolerated dose MTD For the secondary objectives pharmacokineticsPK survival of CAR-T cells in vivo pharmacodynamics PD and efficacy in RR B cell NHL will be evaluated
This study flow comprises of a screening phase 28 days prior to apheresis apheresis phase occur upon enrollment 10 days prior to infusion lymphodepletion phase from Day -5 to Day -3 infusion of CD19CD22BCMA CAR-T cells on Day0 DLT assessments phase from Day1 to Day 28 and post-treatment follow-up phase Day 29 and up to end of the study
This study flow comprises of a screening phase 28 days prior to apheresis apheresis phase occur upon enrollment 10 days prior to infusion lymphodepletion phase from Day -5 to Day -3 infusion of CD19CD22BCMA CAR-T cells on Day0 DLT assessments phase from Day1 to Day 28 and post-treatment follow-up phase Day 29 and up to end of the study
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