NCT06886139Not yet recruitingPhase 2

A Phase 2 Study of TRS005 in Patients With CD20-positive R/R DLBCL.

A Multicenter, Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of TRS005 in Patients With CD20-Positive Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 139 (estimated)
First submitted: 14 Mar 2025
Start date: Sept 2025
Primary completion date: Jan 2027
Lead sponsor: Zhejiang Teruisi Pharmaceutical Inc.
Diseases: Diffuse large B-cell lymphoma
NCT number: NCT06886139

What you commit to

Study type: Interventional · Phase 2
Planned participants: 139
From Sept 2025 to the primary completion date, Jan 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

≥ 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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Participants must have a life expectancy of ≥3 months.
For women of childbearing potential and men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. For women of childbearing potential, a negative serum pregnancy test result within 7 days before the first administration.
All participants and/or their parents or legal guardians must sign a written informed consent form.
- Main 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.
Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath, etc.).
Active of autoimmune disease or immune deficiency.
Accompanied significant cardiovascular disease.
Participants who received autologous stem cell transplantation and CAR-T within 3 months prior to first administration; Participants who have received allogeneic stem cell transplantation in the past.
Participants must not have an uncontrolled infection.
Various vaccines were inoculated within 28 days prior to first administration.
Participate in clinical trials of other drugs or medical devices within 28 days prior to first administration.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Pregnancy and/or active Breast Feeding.
Investigators assessed as unsuitable to participate in this study for other reasons.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Chinese Academy of Medical Sciences Cancer Hospital Coordinator of this site? Confirm its status	Beijing	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.