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CD20-positive Diffuse Large B-Cell LymphomaPhase 2NCT06886139

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

A Phase 2 study testing TRS005 in people with CD20-positive Diffuse Large B-Cell Lymphoma, run by Zhejiang Teruisi Pharmaceutical Inc. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TRS005
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
1 siteChina
Study dates
Sep 2025to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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.
Show all 31Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chen Wang contact

(+86)18832374527

chen.wang@teruisipharm.com

China1 site

  • Chinese Academy of Medical Sciences, Cancer Hospital

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: 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)

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.

Read the 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 endpoints were objective response rate (ORR) assessed by Independent Review Committee (IRC). Participants were assessed for efficacy at the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days). Tumor responses were assessed by computerized tomography (CT) or positron emission tomography-computerized tomography (PET-CT) scanning per the Lugano 2014 criteria. The safety were assessed per the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Being tested
TRS005

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRS005Drug

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

Study groups in NCT06886139
Study groupRoleWhat they receive
TRS005ExperimentalRecombinant 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.
Receives: Drug: TRS005

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)

  1. ORR, Objective Response Rate

    Investigator-assessed confirmed ORR per Lugano 2014 criteria will be determined in the intention-to-treat (ITT) population.

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

  2. DCR, Disease Control Rate

    DCR is defined as the percentage of participants who have achieved complete response, partial response and stable disease to a therapeutic intervention. Investigator-assessed and IRC confirmed DCR per Lugano 2014 criteria.

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

  3. PFS, Progression-free survival

    PFS is defined as the time from the start of treatment to progressive disease (PD) or death due to any cause in the absence of documented PD. Investigator-assessed and IRC confirmed PFS per Lugano 2014 criteria.

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

  4. DOR, Duration of response

    DOR is defined as the time from the date of the first documentation of response in participants with confirmed objective tumor response (complete response or partial response) to the first documentation of progressive disease (PD) or to death due to any cause in the absence of documented PD. Investigator-assessed and IRC confirmed DOR per Lugano 2014 criteria.

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

  5. TTP, Time to progression

    TTP is defined as the time from the start of treatment to progressive disease (PD). Investigator-assessed and IRC confirmed TTP per Lugano 2014 criteria.

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

  6. OS, Overall survival

    OS is defined as the time from the start of treatment to death due to any cause and will be analyzed by Kaplan-Meier method.

    Measured: 24 months after the end of treatment in the last participant

  7. Number of Participants with Treatment-Related Adverse Events (AEs)

    AEs will be assigned to preferred term using MedDRA and graded according to CTCAE v5.0.

    Measured: Through study completion, an average of 1 year

  8. Number of Participants with Immunogenicity

    ADA will be assessed in all participants. NAb will be assessed in samples that are ADA positive.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
139 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06886139
Sponsor's protocol ID
TRS00502001
Status last verified
Apr 2025
First submitted
14 Mar 2025
Last updated
22 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TRS005 in people with CD20-positive Diffuse Large B-Cell Lymphoma, run by Zhejiang Teruisi Pharmaceutical Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chen Wang ((+86)18832374527, chen.wang@teruisipharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR, Objective Response Rate (time frame: At the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06886139.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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