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A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma
Sponsor: Qilu Pharmaceutical Co., Ltd.
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-08-30
Completion Date
2027-01-31
Last Updated
2024-07-15
Healthy Volunteers
No
Conditions
Interventions
QLS4131 Injection
Participants confirming to the eligibility criteria will be assigned to 1 of the 9 dose groups (0.06/0.3/1 \~ 600 ug/kg, respectively) based on the sequence of inclusion.
Locations (1)
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China