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

NCT06886139 | Not Yet Recruiting Phase 2

• 1 other identifier: TRS00502001
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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 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.

Conditions

CD20-positive Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)

Secondary Outcomes (8)

• ORR, Objective Response Rate

  At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)

• DCR, Disease Control Rate

  At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)

• PFS, Progression-free survival

  At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)

• DOR, Duration of response

  At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)

• TTP, Time to progression

  At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)

Study Arms (1)

TRS005

EXPERIMENTAL

Recombinant anti-CD20 monoclonal antibody-MMAE conjugte for injection (TRS005). TRS005 at a dose of 1.8 mg/kg intravenously on day 1 of each 21-day cycle.

Drug: TRS005

Interventions

TRS005 DRUG

Recombinant anti-CD20 monoclonal antibody-MMAE conjugte for injection. To be used under medical supervision.

TRS005

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Teruisi Pharmaceutical Inc.: lead

Study Sites (1)

Chinese Academy of Medical Sciences, Cancer Hospital

Beijing, Beijing Municipality, 100021, China

Location

Study Officials

• Yuankai Shi, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Wang

CONTACT

(+86)18832374527; chen.wang@teruisipharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-04

Locations

CN (1)