A Phase 1b, Multicenter, Open-Label, Study to Investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Anti-MICA/MICB monoclonal antibody
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Mt. Sinai
New York, New York, United States
Proportion of participants reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence of AEs and SAEs using MedDRA
Time frame: baseline through 3-week treatment period
Changes in Eastern Cooperative Oncology Group (ECOG) performance
ECOG Scores are a functional scale ranging from 0 (Fully active, able to carry out all pre-disease activities without restrictions) to 5 (Death)
Time frame: Up to 2 years
Incidence of Dose-Limiting toxicity (DLTs)
Maximum Tolerated Dose (MTD) is reached if 2 or more patients experience a DLT at a dose level
Time frame: up to 2 years
Best Overall Response (BOR) per patient
The best response defined by the International Myeloma Working Group (IMWG) criteria recorded throughout the study including unscheduled assessments
Time frame: up to 2 years
Overall Response Rate (ORR)
The proportion of patients who achieve a partial response or better (e.g., Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) or stringent Complete Response (sCR), according to IMWG response criteria
Time frame: up to 2 years
Duration of Response (DoR)
The time from the earliest date of documented response to the first documented disease progression or death, whichever occurs first.
Time frame: up to 2 years
Clinical Benefit Rate (CBR)
The proportion of patients with a best overall response of CR, PR and stable disease (SD), according to IMWG response criteria
Time frame: up to 2 years
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Memorial Sloan Kettering (MSK)
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Levine Cancer Institute
Winston-Salem, North Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Progression Free Survival (PFS)
The time from date of first dose until the earliest date of disease progression, or death from any cause, whichever occurs first.
Time frame: up to 2 years
Overall Survival (OS)
Time from the date of first dose to date of death due to any cause.
Time frame: up to 2 years