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

Last updated: June 18, 2025
Sponsor: Zhejiang Teruisi Pharmaceutical Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoma, B-cell

Treatment

Recombinant CD20 monoclonal antibody-MMAE conjugte for injection

Clinical Study ID

NCT05395533
TRS00501001
  • Ages > 18
  • All Genders

Study 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) characteristics of TRS005 by intravenous drip.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed CD20-positive B-cell non-Hodgkin lymphoma;

  2. Relapse or refractory after receiving at least 2 standard treatmentregimens;(Definition of refractory: Patients who did not reach PR in two cycles orCR in four cycles);

  3. At least 1 measurable tumor lesion, the maximum transverse diameter of theintranodal 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 2018guidelines;

  4. Previously received anti-tumor treatment (such as radiotherapy, chemotherapy,hormone therapy, biotherapy, immunotherapy) at least 28 days before the firstadministration of this study; chemotherapy and hormono therapy should be at least 14days before the first administration of this study; Chinese medicine anti-tumortreatment should be at least 7 days before the first administration of this study

  5. The toxicity of previous anti-tumor treatment has been restored to ≤ grade 1 asdefined by NCI-CTCAE v5.0 (except for alopecia; see Inclusion Criterion 6 forhemoglobin and renal function);

  6. The laboratory test results must meet the following requirements: (It is not allowedto give any blood components, short acting cell growth factor, albumin, etc., within 7 days before laboratory examination; long acting cell growth factor is not allowedto be given within the first 14 days):

  • 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 timesthe upper limit of normal, (AST and/or ALT ≤ 5 times the upper limit of normalare 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 treatmentbefore enrollment) International normalized ratio (INR) ≤ 1.5 times the upperlimit of normal and activated partial thromboplastin time (APTT) ≤ 1.5 timesthe 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 ofthe lungs for carbon monoxide (DLCO) ≥ 50% of predicted value;

  1. ≥ 18 years , gender is not limited;

  2. ECOG performance status 0-1;

  3. Life expectancy of greater than 3 months;

  4. Female and male patients of childbearing age and their spouses are willing to carryout adequate contraception throughout the study period, and female patients ofchildbearing age must have negative serum pregnancy test within 7 days before thefirst administration;

  5. Patients voluntarily agree to participate in the study and to sign the informedconsent form.

Exclusion

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded:

  1. A clear history of drug allergy, and a history of ingredient allergy toheterogeneous proteins, biological agents or test drugs;

  2. Active hepatitis B or C, or human immunodeficiency virus (HIV) antibody positive;

  3. Those who are positive for syphilis antibodies and confirmed to be unresolved;

  4. Tumor-infiltrating diseases of the central nervous system;

  5. Accompanied by peripheral or central nervous system diseases;

  6. Investigator-assessed diabetes uncontrolled by drug therapy;

  7. Uncontrollable or symptomatic pleural/abdominal/pelvic effusion or pericardialeffusion;

  8. Patients with other malignancies within the past 5 years;

  9. With active autoimmune diseases (such as systemic lupus erythematosus, rheumatoidarthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia,etc.);

  10. Accompanied by the following serious cardiovascular diseases or central nervoussystem diseases:

  11. Myocardial infarction in nearly 6 months of screening period;

  12. Unstable angina pectoris in the screening period of nearly 3 months;

  13. Cardiac insufficiency (cardiac function grade ≥ NYHA class II);

  14. Severe arrhythmia (e.g., persistent ventricular tachycardia, ventricularfibrillation);

  15. Prolonged QTc interval (male > 450 ms, female > 470 ms);

  16. Second or third degree heart block;

  17. Drug-poorly controlled hypertension (systolic blood pressure > 160mmHg ordiastolic blood pressure > 100mmHg);

  18. Cerebrovascular accident (CVA) or transient ischemic attack (TIA), etc., within 6 months before the administration.

  19. Other serious diseases, including but not limited to active peptic ulcer, activehemorrhage, venous thromboembolic event (VTE) and severe interstitial lung disease;

  20. Accompanied by other serious diseases and serious active infections (such aspneumonia, active tuberculosis, etc.);

  21. Received hematopoietic growth factor treatment within 1 week prior to firstadministration, including colony stimulating factor, interleukin or bloodtransfusion;

  22. 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 daysor immunosuppressive treatment;

  23. Various vaccines were inoculated within 1 month prior to first administration;

  24. Major surgery (except diagnostic biopsy) within 1 month prior to firstadministration;

  25. Patients who received autologous stem cell transplantation within 2 months prior tofirst administration;

  26. Patients who have received allogeneic stem cell transplantation in the past;

  27. Patients with infusion reaction above grade III after previous monoclonal antibodytreatment;

  28. Participate in clinical trials of other drugs or medical devices within 1 monthprior to first administration;

  29. Patients previously treated with CAR-T;

  30. Investigators assessed as unsuitable to participate in this study for other reasons.

Study Design

Total Participants: 147
Treatment Group(s): 1
Primary Treatment: Recombinant CD20 monoclonal antibody-MMAE conjugte for injection
Phase: 1
Study Start date:
September 08, 2020
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Chinese Academy of Medical Sciences, Cancer Hospital

    Beijing, Beijing 100021
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center (SYSUCC)

    Guangzhou, Guangdong 510000
    China

    Site Not Available

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

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215000
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital (TMUCIH)

    Tianjin, Tianjin 300000
    China

    Site Not Available

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