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CD20-positive B-cell Non-Hodgkin LymphomaPhase 1NCT05395533

A Phase 1 Study of TRS005 in Patients With R/R CD20-positive B-NHL.

A Phase 1 study testing Recombinant CD20 monoclonal antibody-MMAE conjugte for injection in people with CD20-positive B-cell Non-Hodgkin Lymphoma, run by Zhejiang Teruisi Pharmaceutical Inc. at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial is a multicenter, open, single arm, dose increasing and extended clinical trial. The dose was increased according to the "3 + 3" rule. Patients with recurrent or refractory CD20 positive B-cell non-Hodgkin's lymphoma were selected to evaluate the safety, tolerance (DLT, MTD) and pharmacokinetic (PK)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Recombinant CD20 monoclonal antibody-MMAE conjugte for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
6 sitesChina
Study dates
8 Sep 2020to 31 Dec 2025
Phase
Phase 1
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

  • Histologically confirmed CD20-positive B-cell non-Hodgkin lymphoma;
  • Relapse or refractory after receiving at least 2 standard treatment regimens;（Definition of refractory: Patients who did not reach PR in two cycles or CR in four cycles）;
  • At least 1 measurable tumor lesion, the maximum transverse diameter of the intranodal lesion should be > 1.5 cm and that of the extranodal lesion should be > 1.0 cm; CLL/SLL patients have treatment indications according to iwCLL 2018 guidelines;
  • Previously received anti-tumor treatment (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy) at least 28 days before the first administration of this study; chemotherapy and hormono therapy should be at least 14 days before the first administration of this study; Chinese medicine anti-tumor treatment should be at least 7 days before the first administration of this study
  • The toxicity of previous anti-tumor treatment has been restored to ≤ grade 1 as defined by NCI-CTCAE v5.0 (except for alopecia; see Inclusion Criterion 6 for hemoglobin and renal function)；
  • The laboratory test results must meet the following requirements: (It is not allowed to give any blood components, short acting cell growth factor, albumin, etc., within 7 days before laboratory examination; long acting cell growth factor is not allowed to be given within the first 14 days):
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  • Hematology: Absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets (PLT) ≥ 90×109/L, hemoglobin (HGB) ≥ 90 g/L;
  • Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal, total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal, (AST and/or ALT ≤ 5 times the upper limit of normal are allowed in patients with liver involvement);
  • Renal function: Serum creatinine (Cr) ≤ 2 times the upper limit of normal;
  • Coagulation function: (patients who have not received anticoagulant treatment before enrollment) International normalized ratio (INR) ≤ 1.5 times the upper limit of normal and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal;
  • Pulmonary function test for patients with previous lung underlying disorders: measured/predicted value of vital capacity (VC) ≥ 60%, or diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50% of predicted value;
  • ≥ 18 years , gender is not limited;
  • ECOG performance status 0-1;
  • Life expectancy of greater than 3 months;
  • Female and male patients of childbearing age and their spouses are willing to carry out adequate contraception throughout the study period, and female patients of childbearing age must have negative serum pregnancy test within 7 days before the first administration;
  • Patients voluntarily agree to participate in the study and to sign the informed consent form.

Who cannot join

  • Patients who meet any of the following criteria will be excluded:
  • A clear history of drug allergy, and a history of ingredient allergy to heterogeneous proteins, biological agents or test drugs;
  • Active hepatitis B or C, or human immunodeficiency virus (HIV) antibody positive;
  • Those who are positive for syphilis antibodies and confirmed to be unresolved;
  • Tumor-infiltrating diseases of the central nervous system;
  • Accompanied by peripheral or central nervous system diseases;
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  • Investigator-assessed diabetes uncontrolled by drug therapy;
  • Uncontrollable or symptomatic pleural/abdominal/pelvic effusion or pericardial effusion;
  • Patients with other malignancies within the past 5 years;
  • With active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, etc.);
  • Accompanied by the following serious cardiovascular diseases or central nervous system diseases:
  • Myocardial infarction in nearly 6 months of screening period;
  • Unstable angina pectoris in the screening period of nearly 3 months;
  • Cardiac insufficiency (cardiac function grade ≥ NYHA class II);
  • Severe arrhythmia (e.g., persistent ventricular tachycardia, ventricular fibrillation);
  • Prolonged QTc interval (male > 450 ms, female > 470 ms);
  • Second or third degree heart block;
  • Drug-poorly controlled hypertension (systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg);
  • Cerebrovascular accident (CVA) or transient ischemic attack (TIA), etc., within 6 months before the administration.
  • Other serious diseases, including but not limited to active peptic ulcer, active hemorrhage, venous thromboembolic event (VTE) and severe interstitial lung disease;
  • Accompanied by other serious diseases and serious active infections (such as pneumonia, active tuberculosis, etc.);
  • Received hematopoietic growth factor treatment within 1 week prior to first administration, including colony stimulating factor, interleukin or blood transfusion;
  • The dosage of steroid hormone (prednisone phase equivalent) used greater than 20mg/ day within 1 month prior to first administration for more than 14 consecutive days or immunosuppressive treatment;
  • Various vaccines were inoculated within 1 month prior to first administration;
  • Major surgery (except diagnostic biopsy) within 1 month prior to first administration;
  • Patients who received autologous stem cell transplantation within 2 months prior to first administration;
  • Patients who have received allogeneic stem cell transplantation in the past;
  • Patients with infusion reaction above grade III after previous monoclonal antibody treatment;
  • Participate in clinical trials of other drugs or medical devices within 1 month prior to first administration;
  • Patients previously treated with CAR-T;
  • Investigators assessed as unsuitable to participate in this study for other reasons.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Chinese Academy of Medical Sciences, Cancer Hospital

    Beijing, Beijing Municipality, 100021

  • Sun Yat-sen University Cancer Center (SYSUCC)

    Guangzhou, Guangdong, 510000

  • Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

  • Tianjin Medical University Cancer Institute & Hospital (TMUCIH)

    Tianjin, Tianjin Municipality, 300000

  • Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Multicenter, Single-arm, Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effectiveness of TRS005 in Patients With Relapsed or Refractory CD20-positive B-NHL

This trial is a multicenter, open, single arm, dose increasing and extended clinical trial. The dose was increased according to the "3 + 3" rule. Patients with recurrent or refractory CD20 positive B-cell non-Hodgkin's lymphoma were selected to evaluate the safety, tolerance (DLT, MTD) and pharmacokinetic (PK) characteristics of TRS005 by intravenous drip.

Read the detailed description

The subjects were screened and examined according to the protocol before enrollment. The dose of the enrolled subjects was increased according to the following 6 dose groups: 0.1mg/kg, 0.5mg/kg, 1.0mg/kg, 1.5mg/kg, 1.8mg/kg, 2.1mg/kg. The incremental process is divided into groups according to the principle of 3 + 3 dose increment. The subjects randomly receive intravenous drip of TRS005 in chronological order. Each subject first carries out a single dose study, and then carries out multiple continuous doses. The first dose is given once in D1. After 21 days of observation, it is decided whether to continue multiple continuous doses according to the situation. They are given once in C2D1, C3D1, C4D1, C5D1, C6D1, or more cycles respectively, and received treatment until progressive disease or unacceptable toxicity. During the dose escalation process, the investigators will perform dose expansion according to the clinical benefits of different dose groups.

Being tested
Recombinant CD20 monoclonal antibody-MMAE conjugte for injection

What participants receive

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

  • Recombinant CD20 monoclonal antibody-MMAE conjugte for injectionDrug

    Also called TRS005

    The dose of the enrolled subjects was increased according to the following 6 dose groups: 0.1mg/kg, 0.5mg/kg, 1.0mg/kg, 1.5mg/kg, 1.8mg/kg, and 2.1mg/kg.

Study groups in NCT05395533
Study groupRoleWhat they receive
Recombinant CD20 monoclonal antibody-MMAE conjugte for injection (TRS005)ExperimentalTo evaluate the safety and tolerability of TRS005 in patients with recurrent or refractory CD20-positive B-cell non-Hodgkin's lymphoma with treatment at one or more times, and to recommend the dose for phase II clinical trials (RP2D).
Receives: Drug: Recombinant CD20 monoclonal antibody-MMAE conjugte for injection

What is being measured

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

  1. Number of Participants With Dose-limiting Toxicity

    DLTs were defined as specific events which occurred in the 21-day DLT evaluation period of the dose escalation part, except any events that were clearly due to underlying disease or extraneous causes. The grading and severity of events were based on the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: Cycle 1(Days 1-21)

  2. MTD，Maximum Tolerated Dose

    After the dose increment is completed, the incidence of DLT in each dose group is summarized and analyzed. The highest dose group closest to 1 / 3 of the preset incidence of DLT is MTD

    Measured: Cycle 1(Days 1-21)

  3. Number of Participants With Treatment-emergent Adverse Event (TEAE)

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 5.0 (NCI-CTCAE, v5.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).

    Measured: Baseline up to approximately 5 years

Secondary outcomes (9)

  1. Number of Participants With ADA/Nab

    Evaluate the changes of anti drug antibody and neutralizing antibody produced by the subjects.

    Measured: Baseline up to approximately 5 years

  2. ORR, overall response rate

    Summarize the number and percentage of objective remission (Complete remission (CR) or Partial remission (PR))

    Measured: Baseline up to approximately 5 years

  3. DOR, duration of response

    DOR was defined as the time from the documentation of first tumor response (CR or PR) to disease progression or death.

    Measured: Baseline up to approximately 5 years

  4. PFS, progression-free survival

    PFS was defined as the time between start of treatment and the first documentation of progression, or death.

    Measured: Baseline up to approximately 5 years

  5. OS, overall survival

    OS was defined as the time between the start of treatment and death from any cause.

    Measured: Baseline up to approximately 5 years

  6. Cmax

    Peak concentration. Obtained directly from the measured data of blood drug concentration-time.

    Measured: At the day3/day5/day8/day15 in cycle 1and 4；and at the first day of Cycle 1-5 (each cycle is 21 days)

  7. AUC0-t

    Area under the curve from zero to the lowest detectable plasma concentration. Calculated by linear trapezoidal rule:

    AUC(i, i+1)=(Ti+1-Ti)(Ci+Ci+1)/2, AUC 0-t is the sum of all AUC (I, I + 1).

    Measured: At the day3/day5/day8/day15 in cycle 1and 4；and at the first day of Cycle 1-5 (each cycle is 21 days)

  8. AUC0-∞

    Area under the curve extrapolated from zero to infinity time. AUC0-∞=AUC0-t+Ct/λ z(Ct is the last measurable plasma concentration)

    Measured: At the day3/day5/day8/day15 in cycle 1and 4；and at the first day of Cycle 1-5 (each cycle is 21 days)

  9. Tmax

    Peak time. Obtained directly from the measured data of blood drug concentration-time.

    Measured: At the day3/day5/day8/day15 in cycle 1and 4；and at the first day of Cycle 1-5 (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 posted27 May 2022
  2. Study start8 Sep 2020
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Dec 2025 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05395533
Sponsor's protocol ID
TRS00501001
Status last verified
Jun 2025
First submitted
19 May 2022
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant CD20 monoclonal antibody-MMAE conjugte for injection in people with CD20-positive B-cell Non-Hodgkin Lymphoma, run by Zhejiang Teruisi Pharmaceutical Inc. at 6 sites 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 16 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-limiting Toxicity (time frame: Cycle 1(Days 1-21)). The study lists 3 primary outcomes in all. 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 NCT05395533.

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 25 Jun 2025.

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