This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with relapsed/refractory (R/R) B-cell malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Each participant receives MTM-H-001 Injection
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Langfang, Hebei, China
Incidence of Dose-Limiting Toxicity (DLT)
Percentage of participants experiencing DLTs
Time frame: 42 days following first dose of MTM-H-001 for each participant
Objective response rate (ORR)
Percentage of participants who achieve complete response (CR) and partial response (PR) (evaluated by the investigator according to the criteria of Lugano 2014 and iWCLL 2018).
Time frame: Throughout the study, up to 24 months
Disease control rate (DCR)
Percentage of participants who achieve complete response (CR), partial response (PR) and stable disease (SD).
Time frame: Throughout the study, up to 24 months
Time to response (TTR)
Time from the first dose of MTM-H-001 to the first documented response (CR or PR).
Time frame: Throughout the study, up to 24 months
Duration of response (DOR)
Time from the first documented objective response (CR or PR) to the first documented progressive disease (PD) or death from any cause (whichever occurs first).
Time frame: Throughout the study, up to 24 months
Event-free survival (EFS)
Time from the first dose of MTM-H-001 to the first documented PD or relapse, initiation of any new anti-lymphoma treatment, or death from any cause (whichever occurs first).
Time frame: Throughout the study, up to 24 months
Progression free survival (PFS)
Time from the first dose of MTM-H-001 to the first documented PD or death from any cause (whichever occurs first).
Time frame: Throughout the study, up to 24 months
Overall survival (OS)
Time from the first dose of MTM-H-001 to death from any cause.
Time frame: Throughout the study, up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.