A Phase 2 Study of TRS005 in Patients With CD20-positive R/R DLBCL. (NCT06886139) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2 Study of TRS005 in Patients With CD20-positive R/R DLBCL.
China139 participantsStarted 2025-09
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 18 years, gender is not limited.
. The participants need to undergo pathological biopsy of tumor tissue.. Confirmed by histopathology with CD20-positive DLBCL, except for High-grade B-cell lymphoma with MYC and BCL2 rearrangements (HGBL-DH), and histologic transformed DLBCL according to the WHO 2022 revised classification standards.
. Relapse or refractory after at least 2 lines of sufficient standard treatment regimens.
. Not considered to be eligible for Autologous Stem Cell Transplant (ASCT).
. Have measurable disease, including at least 1 nodal site measuring \>1.5 cm or 1 extranodal site measuring \>1.0 cm in longest dimension on computed tomography (CT).
. Previously received anti-tumor treatment such as radiotherapy, biotherapy, immunotherapy at least 28 days before the first administration of this study; chemotherapy at least 21 days before the first administration of this study; hormone therapy at least 14 days before the first administration of this study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ORR, Objective Response Rate
Timeframe: At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)
. Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 (CTCAE 5.0) to prior anti-cancer therapy.
. Organ Function Requirements：Adequate hematologic, renal, and hepatic function.
Exclusion criteria
. A history of drug allergy to components of the test drug, xenoproteins, biological agents, etc., or severe infusion reaction after previous monoclonal antibody treatment.
. Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load; Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load; Human immunodeficiency virus (HIV) seropositive.
. Tumor-infiltrating diseases of the central nervous system.
. Prior systemic treatment of lymphoma with MMAE-containing ADC drugs.
. Prior treated with radiotherapy covering more than 30% of the bone marrow area.
. ≥Grade 2 or greater baseline peripheral neuropathy.
. Investigator-assessed diabetes uncontrolled by drug therapy.
. Participants with other malignancies within the past 5 years.