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NCT Number: NCT07035379

A Phase I/II Study of TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone（T-CHP） in Previously Untreated Patients With CD20-positive DLBCL

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.

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Key information

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chinese Academy of Medical Sciences, Cancer Hospital

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 therapy.
  • 6. Clinically significant third space fluid accumulation.
  • 7. Patients with other malignancies within the past 5 years.
  • 8. With active autoimmune diseases.
  • 9. Accompanied by serious cardiovascular diseases.
  • 10. Accompanied by serious diseases and serious active infections.
  • 11. The dosage of steroid hormone (prednisone phase equivalent) used greater than 20mg/ day within 28 days prior to first administration for more than 14 consecutive days, or immunosuppressive treatment.
  • 12. Various vaccines were inoculated within 28 days prior to first administration;
  • 13. Major surgery (except diagnostic biopsy) within 28 days prior to first administration or during the study period.
  • 14. Participate in clinical trials of other drugs or medical devices within 28 days prior to first administration.
  • 15. Serious medical or psychiatric illness likely to interfere with participation in this study.
  • 16. Investigators assessed as unsuitable to participate in this study for other reasons.

Treatment and study plan

TRS005

Drug

TRS005 will be administered at a starting dose of 0.8mg/kg IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles (up to 8).

Cyclophosphamide

Drug

Cyclophosphamide will be administered at 750 milligrams per square meter (mg/m^2) IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.

Doxorubicin

Drug

Doxorubicin will be administered at 50 mg/m^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.

Prednisolone

Drug

Prednisolone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.

Primary outcomes

  1. Part I: Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD)

    Time frame: Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21)

    All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD.

  2. Part I and II: Adverse Events

    Time frame: Day 1 up to approximately 6 months

    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).

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: At the end of treatment (Month 6)

    The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on Lugano 2014 criteria

  2. Duration of Response (DOR)

    Time frame: Up to 24 months

    Duration of Overall Response (DOR), estimated using the Kaplan Meier method, is measured from Lugano 2014 criteria are met for CR or PR (whichever is first recorded) , until the first date that recurrent or progressive disease is objectively documented. Patients without progressive disease are censored at the date of last disease assessment.

  3. Progression-Free Survival (PFS)

    Time frame: Up to 24 months

    Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) per Lugano criteria or death, or is censored at time of last disease assessment.

  4. Overall Survival (OS)

    Time frame: Up to 24 months

    Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.

  5. Immunogenicity

    Time frame: At the end of treatment (Month 6)

    ADA will be assessed in all participants. NAb will be assessed in samples that are ADA positive.

  6. Serum concentration

    Time frame: At the end of cycle 4 (each cycle is 21 days)

    Total TRS005, TRS005 unconjugated MMAE, and antibody-conjugated Mono-Methyl Auristatin E [acMMAE]

Study contacts

Contact information is provided by the study sponsor or research team.

Chen Wang

CONTACT

[email protected]

(+86)18832374527

Sponsors and collaborators

Lead sponsor

Zhejiang Teruisi Pharmaceutical Inc.

Industry

Registry information

Official study title

A Phase I/II Study Evaluating the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone（T-CHP） in Previously Untreated Patients With CD20-positive DLBCL

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jun 25, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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