CLN-978-001 is a Phase 1, open-label, dose escalation and dose expansion study of CLN-978 in patients with Relapse/Refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
CD19xCD3 T cell engager
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Safety and tolerability of CLN-978 based on AEs, AESIs, and SAEs
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs); incidence of dose interruptions and delays
Time frame: 24 months
Define dose regimen for CLN-978
Dose-limiting Toxicities (DLTs)
Time frame: 24 months
Assess preliminary efficacy of CLN-978 by overall response in patients with selective histologies of R/R B-NHL
Overall response rate (ORR)
Time frame: 24 months
Assess preliminary efficacy of CLN-978 by complete response in patients with selective histologies of R/R B-NHL
Complete response (CR)
Time frame: 24 months
Assess preliminary efficacy of CLN-978 by duration of response in patients with selective histologies of R/R B-NHL
Duration of response (DOR)
Time frame: 24 months
Select PK parameters of CLN-978: AUC
Area under-the-concentration-time curve of CLN-978
Time frame: 24 months
Select PK parameters of CLN-978: Cmax
Maximum concentration of CLN-978
Time frame: 24 months
Select PK parameters of CLN-978: Half-life
Half-life of CLN-978
Time frame: 24 months
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Hackensack University Medical Center
Hackensack, New Jersey, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Immunogenicity of CLN-978 and potential impact on drug exposure
Incidence of anti-drug antibodies to CLN-978
Time frame: 24 months