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 range18 Years
SexALL
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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)；
✓. 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;
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)