A Multicenter, Single-arm, Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effectiveness of TRS005 in Patients With Relapsed or Refractory CD20-positive B-NHL
Sponsor study identifier
interventional
147
1 country
6
Study Start
September 8, 2020
Actual (reported)Primary Completion
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This trial is a multicenter, open, single arm, dose increasing and extended clinical trial. The dose was increased according to the "3 + 3" rule. Patients with recurrent or refractory CD20 positive B-cell non-Hodgkin's lymphoma were selected to evaluate the safety, tolerance (DLT, MTD) and pharmacokinetic (PK) characteristics of TRS005 by intravenous drip.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 8, 2020
Actual (reported)May 19, 2022
Actual (reported)May 27, 2022
Actual (reported)July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of Participants With Dose-limiting Toxicity
DLTs were defined as specific events which occurred in the 21-day DLT evaluation period of the dose escalation part, except any events that were clearly due to underlying disease or extraneous causes. The grading and severity of events were based on the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Cycle 1(Days 1-21)
MTD，Maximum Tolerated Dose
After the dose increment is completed, the incidence of DLT in each dose group is summarized and analyzed. The highest dose group closest to 1 / 3 of the preset incidence of DLT is MTD
Cycle 1(Days 1-21)
Number of Participants With Treatment-emergent Adverse Event (TEAE)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 5.0 (NCI-CTCAE, v5.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
Baseline up to approximately 5 years
Number of Participants With ADA/Nab
Baseline up to approximately 5 years
ORR, overall response rate
Baseline up to approximately 5 years
DOR, duration of response
Baseline up to approximately 5 years
PFS, progression-free survival
Baseline up to approximately 5 years
OS, overall survival
Baseline up to approximately 5 years
To evaluate the safety and tolerability of TRS005 in patients with recurrent or refractory CD20-positive B-cell non-Hodgkin's lymphoma with treatment at one or more times, and to recommend the dose for phase II clinical trials (RP2D).
The dose of the enrolled subjects was increased according to the following 6 dose groups: 0.1mg/kg, 0.5mg/kg, 1.0mg/kg, 1.5mg/kg, 1.8mg/kg, and 2.1mg/kg.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chinese Academy of Medical Sciences, Cancer Hospital
Beijing, Beijing Municipality, 100021, China
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, 510000, China
Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Tianjin Medical University Cancer Institute & Hospital (TMUCIH)
Tianjin, Tianjin Municipality, 300000, China
Yuankai Shi, MD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
147 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2022
First Posted
May 27, 2022
Study Start
September 8, 2020
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 25, 2025
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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