Ruijin Hospital
Shanghai, China
Location status: Recruiting
NCT Number: NCT06725524
This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. The first part is a dose-escalation part using a 3+3 design with up to 6 dose(0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 12 mg/kg and 20 mg/kg) escalation cohorts at increasing levels. The second part is a dose-expansion part at R2PD dose to assess preliminary efficacy of JMT601.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 1
Shanghai, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
intravenous infusion on day 1 once a week
Time frame: DLTs and MTD: Up to 28 days after the first dose
Time frame: TEAEs: Up to 90 days after last dose
Time frame: Up to 12 months
Defined as the proportion of participants with complete response or partial response measured by Lugano 2014
Time frame: Up to 12 months
Defined as the time from complete response or partial response to progression disease or death
Time frame: Up to 12 months
Defined as the time from initiation of treatment to progression disease or death
Time frame: Up to 12 months
Defined as the time from initiation of treatment to death of any cause
Time frame: Up to 12 months
Aera under the curve from 0 to the last measurable concentration
Time frame: Up to 12 months
Aera under the curve from 0 to the infinite time
Time frame: Up to 12 months
time to maximum concentration
Time frame: Up to 12 months
terminal phase half-life
Time frame: Up to 12 months
clearance
Time frame: Up to 12 months
volume
Time frame: Up to 12 months
maximum concentration
Time frame: Up to 12 months
minimum concentration
Time frame: Up to 12 months
accumulation ratio
Contact information is provided by the study sponsor or research team.
Shanghai JMT-Bio Inc.
Industry
A Phase 1, Open-Label, Multi-center Study Evaluating the Safety and Tolerability of of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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