Status:
NOT_YET_RECRUITING
A Phase 2 Study of TRS005 in Patients With CD20-positive R/R DLBCL.
Lead Sponsor:
Zhejiang Teruisi Pharmaceutical Inc.
Conditions:
CD20-positive Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 treatme...
Detailed Description
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 en...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT06886139
Start Date
September 1 2025
End Date
September 1 2027
Last Update
August 22 2025
Active Locations (1)
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1
Chinese Academy of Medical Sciences, Cancer Hospital
Beijing, Beijing Municipality, China, 100021