A Phase 1 Study of TRS005 in Patients With R/R CD20-positive B-NHL. (NCT05395533) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Phase 1 Study of TRS005 in Patients With R/R CD20-positive B-NHL.
China147 participantsStarted 2020-09-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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)；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Dose-limiting Toxicity
Timeframe: Cycle 1(Days 1-21)
2
MTD，Maximum Tolerated Dose
Timeframe: Cycle 1(Days 1-21)
3
Number of Participants With Treatment-emergent Adverse Event (TEAE)
. 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):
. ≥ 18 years , gender is not limited;
. ECOG performance status 0-1;
Exclusion criteria
. 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;
. 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;