This study consists of two parts. Phase Ia is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG001. Phase Ib is a dose expansion study to assess the preliminary efficacy of MRG001 in patients with CD20-positive relapsed or refractory B-cell NHL at the confirmed RP2D. The safety, tolerability, pharmacokinetic (PK) and immunogenicity of MRG001 will be evaluated in both parts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Administrated intravenously
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China
Adverse Events (AEs)
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
Time frame: Baseline to 90 days after the last dose of study treatment.
Maximum Tolerated Dose (MTD)
The highest dose confirmed wherein ≤ 1/6 of patients in a treatment cohort experiences a dose-limiting toxicity (DLT) within 21 days after the first dose of study treatment.
Time frame: DLT will be evaluated during the first treatment cycle (Day 1-21).
Recommended Phase II Dose (RP2D)
The dose level of MRG001 recommended for further phase II clinical studies.
Time frame: Baseline to study completion (up to 15 months).
PK parameter: Concentration-time curve
Plot of drug concentration changing with time after drug administration.
Time frame: Baseline to 90 days after the last dose of study treatment.
Immunogenicity
The proportion of patients with positive ADA immunogenicity results.
Time frame: Baseline to 30 days after the last dose of study treatment
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with CR and PR.
Time frame: Baseline to study completion (up to 15 months)
Duration of Response (DoR)
DoR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGSun Yat-sen University Cancer Hospital
Guangzhou, Guangdong, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGZhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGHarbin First Hospital
Harbin, Heilongjiang, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGThe First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGShengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITING...and 2 more locations
Time frame: Baseline to study completion (up to 15 months)
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment.
Time frame: Baseline to study completion (up to 15 months)
Progression Free Survival (PFS)
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Time frame: Baseline to study completion (up to 15 months)
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Time frame: Baseline to study completion (up to 15 months)