Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655519
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
An Exploratory Study of RD140 Injection in Patients With RelapsedRefractory Multiple Myeloma or Plasma Cell Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Exploratory Study of Fully Human Anti-B-Cell Maturation Antigen BCMAG Protein-coupled Receptor Class C Group 5 Member GPRC5D Chimeric Antigen Receptor T Cells RD140 in Patients With RelapsedRefractory Multiple Myeloma or Plasma Cell Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center open clinical study divided into two phases of dose escalation and dose expansion to observe the safety and efficacy of RD140 injection at different doses in patients with relapsedrefractory multiple myeloma or plasmacytic leukemia
Detailed Description:
This study is divided into two stages dose escalation and dose extension The 33 dose escalation design was adopted in the dose escalation stage and three dose escalation dose groups of 10105 CARTChimeric Antigen Receptor T Cell cellskg 30105 CART cellskg and 60105 CART cellskg were preset Each dose group level included 3-6 subjects with a single dose The objective is to preliminarily observe the safety and tolerability pharmacokinetics pharmacodynamics and immunogenicity of RD140 injection at different doses in patients with relapsedrefractory multiple myeloma RRMM or plasma cell leukemia and provide evidence for dose expansion phase
In the dose expansion phase 1 to 2 dose groups were selected for expansion based on the dose escalation phase and 3 to 6 subjects were included in each extended dose group to further evaluate the safety efficacy pharmacokinetics and pharmacodynamics of RD140 injection in the treatment of RRMM or plasma cell leukemia
In the dose expansion phase 1 to 2 dose groups were selected for expansion based on the dose escalation phase and 3 to 6 subjects were included in each extended dose group to further evaluate the safety efficacy pharmacokinetics and pharmacodynamics of RD140 injection in the treatment of RRMM or plasma cell leukemia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None