A Phase I/II Study of TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone（T-… (NCT07035379) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Phase I/II Study of TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone（T-CHP） in Previously Untreated Patients With CD20-positive DLBCL
China66 participantsStarted 2025-09-01
Plain-language summary
This trial is a multicenter, open-label, single-arm, dose-escalation and dose-expansion clinical trial. The dose was increased according to the "3 + 3" rule. Patients with previously untreated patients with CD20-positive DLBCL were selected to evaluate the safety, tolerance (DLT, MTD), pharmacokinetics, and anti-tumor activity of TRS005 in combination with standard doses of cyclophosphamide, doxorubicin, and prednisone（T-CHP） by intravenous drip every 3 weeks.
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.
Inclusion Criteria:
* 1\. Part I: Age 18 -65 years old; Part II: Aged ≥ 18 years old, both male and female.
* 2\. Previously untreated patients with CD20-positive DLBCL diagnoses by 2022 WHO.
* 3\. Measurable disease of at least 15mm (node)/10mm (extranodal).
* 4\. ECOG performance status 0-2.
* 5\. International Prognostic Index (IPI) score of 2-5.
* 6\. Estimated survival time ≥6 months.
* 7\. Having sufficient organ function.
* 8\. 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.
* 9\. Patients voluntarily agree to participate in the study and to sign the informed consent form.
Exclusion Criteria:
* 1\. Contraindication to any of the individual components of study drugs, including prior receipt of xenoproteins, biological agents.
* 2\. 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.
* 3\. Clinically apparent central nervous system (CNS) lymphoma.
* 4\. Patient has ≥ Grade 2 peripheral neuropathy.
* 5\. Investigator-assessed diabetes uncontrolled by drug t…
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
Part I: Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD)
Timeframe: Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21)