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 range18 Years
SexALL
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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.
✓. 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.
✕
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)
. 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.