Ignite Creation Date:
2024-07-17 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500507
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma
Sponsor:
Qilu Pharmaceutical Co Ltd
Organization:
Qilu Pharmaceutical Co Ltd
Study Overview
Official Title:
Phase I Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics Immunogenicity and Preliminary Effectiveness of QLS4131 Injection in Patients With Relapsed or Refractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose RP2D and to further evaluate the efficacy and safety of QLS4131 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose
Detailed Description:
Multiple myeloma MM is a malignant disease with abnormal proliferation of clonal plasma cell which is often accompanied by multiple osteolytic damage hypercalcemia anemia and kidney damage QLS4131 is a novel tri-specific humanized antibody The study consists 3 periods screening phase treatment phase and a post-treatment follow-up phase The study will evaluate safety tolerability pharmacokinetics and preliminary antitumor activity of QLS4131 administered to participants with relapsed or refractory multiple myeloma Total duration of study is up to 2 years
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