Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
Study NCT ID:
NCT06732232
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed/ Refractory Multiple Myeloma
Sponsor:
Shanghai Cell Therapy Group Co.,Ltd
Organization:
Study Overview
Official Title:
A Dose Escalating Study of CD19/CD22/BCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed/Refractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-11
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 autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory multiple myeloma.
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 CD19/ CD22/BCMA CAR-T therapy in patients with relapsed/refractory multiple myeloma, and determine the maximum tolerated dose (MTD). For the secondary objectives,pharmacokinetics(PK), survival of CAR-T cells in vivo,pharmacodynamics (PD) and efficacy in R/R MM will be evaluated.
This study flow comprises of a screening phase( 30 to10 days prior to infusion), apheresis phase (9 to 8 days prior to infusion), lymphodepletion phase (5 to 3 days prior to infusion) , infusion of CD19/CD22/BCMA 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( 30 to10 days prior to infusion), apheresis phase (9 to 8 days prior to infusion), lymphodepletion phase (5 to 3 days prior to infusion) , infusion of CD19/CD22/BCMA 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:
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?: