This trial is a multicenter, open-label, single-arm, Phase II Study. Patients with CD20 positive recurrent or refractory diffuse large B-cell lymphoma and had failed ≥2 prior lines of standard treatment will be recruited. The purpose of this trial is to evaluate the efficacy, safety, pharmacokinetic (PK) and immunogenicity characteristics of TRS005 via intravenous drip.
The participants were screened and examined according to the protocol before enrollment. Participants received TRS005 at a dose of 1.8 mg/kg intravenously on day 1 of each 21-day cycle. The primary endpoints were objective response rate (ORR) assessed by Independent Review Committee (IRC). Participants were assessed for efficacy at the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days). Tumor responses were assessed by computerized tomography (CT) or positron emission tomography-computerized tomography (PET-CT) scanning per the Lugano 2014 criteria. The safety were assessed per the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Recombinant anti-CD20 monoclonal antibody-MMAE conjugte for injection. To be used under medical supervision.
Chinese Academy of Medical Sciences, Cancer Hospital
Beijing, Beijing Municipality, China
ORR, Objective Response Rate
Objective Response Rate (ORR): the presence of at least one confirmed CR/PR. Independent Review Committee (IRC) confirmed ORR per Lugano 2014 criteria will be determined in the intention-to-treat (ITT) population.
Time frame: At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)
ORR, Objective Response Rate
Investigator-assessed confirmed ORR per Lugano 2014 criteria will be determined in the intention-to-treat (ITT) population.
Time frame: At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)
DCR, Disease Control Rate
DCR is defined as the percentage of participants who have achieved complete response, partial response and stable disease to a therapeutic intervention. Investigator-assessed and IRC confirmed DCR per Lugano 2014 criteria.
Time frame: At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)
PFS, Progression-free survival
PFS is defined as the time from the start of treatment to progressive disease (PD) or death due to any cause in the absence of documented PD. Investigator-assessed and IRC confirmed PFS per Lugano 2014 criteria.
Time frame: At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)
DOR, Duration of response
DOR is defined as the time from the date of the first documentation of response in participants with confirmed objective tumor response (complete response or partial response) to the first documentation of progressive disease (PD) or to death due to any cause in the absence of documented PD. Investigator-assessed and IRC confirmed DOR per Lugano 2014 criteria.
Time frame: At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)
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TTP, Time to progression
TTP is defined as the time from the start of treatment to progressive disease (PD). Investigator-assessed and IRC confirmed TTP per Lugano 2014 criteria.
Time frame: At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)
OS, Overall survival
OS is defined as the time from the start of treatment to death due to any cause and will be analyzed by Kaplan-Meier method.
Time frame: 24 months after the end of treatment in the last participant
Number of Participants with Treatment-Related Adverse Events (AEs)
AEs will be assigned to preferred term using MedDRA and graded according to CTCAE v5.0.
Time frame: Through study completion, an average of 1 year
Number of Participants with Immunogenicity
ADA will be assessed in all participants. NAb will be assessed in samples that are ADA positive.
Time frame: At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)