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

NCT07035379 | Not Yet Recruiting Phase 1

• 1 other identifier: TRS00501003
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (2)

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

  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.

  Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21)

• Part I and II: Adverse Events

  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).

  Day 1 up to approximately 6 months

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  At the end of treatment (Month 6)

• Duration of Response (DOR)

  Up to 24 months

• Progression-Free Survival (PFS)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

• Immunogenicity

  At the end of treatment (Month 6)

Study Arms (1)

TRS005+CHP

EXPERIMENTAL

TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone（T-CHP）

Drug: TRS005; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisolone

Interventions

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).

TRS005+CHP

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.

TRS005+CHP

Doxorubicin DRUG

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

TRS005+CHP

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.

TRS005+CHP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Part I: Age 18 -65 years old; Part II: Aged ≥ 18 years old, both male and female.
• \. Previously untreated patients with CD20-positive DLBCL diagnoses by 2022 WHO.
• \. Measurable disease of at least 15mm (node)/10mm (extranodal).
• \. ECOG performance status 0-2.
• \. International Prognostic Index (IPI) score of 2-5.
• \. Estimated survival time ≥6 months.
• \. Having sufficient organ function.
• \. 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.
• \. Patients voluntarily agree to participate in the study and to sign the informed consent form.

You may not qualify if:

• \. Contraindication to any of the individual components of study drugs, including prior receipt of xenoproteins, biological agents.
• \. 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.
• \. Clinically apparent central nervous system (CNS) lymphoma.
• \. Patient has ≥ Grade 2 peripheral neuropathy.
• \. Investigator-assessed diabetes uncontrolled by drug therapy.
• \. Clinically significant third space fluid accumulation.
• \. Patients with other malignancies within the past 5 years.
• \. With active autoimmune diseases.
• \. Accompanied by serious cardiovascular diseases.
• \. Accompanied by serious diseases and serious active infections.
• \. 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.
• \. Various vaccines were inoculated within 28 days prior to first administration;
• \. Major surgery (except diagnostic biopsy) within 28 days prior to first administration or during the study period.
• \. Participate in clinical trials of other drugs or medical devices within 28 days prior to first administration.
• \. Serious medical or psychiatric illness likely to interfere with participation in this study.

Sponsors & Collaborators

• Zhejiang Teruisi Pharmaceutical Inc.: lead

Study Sites (1)

Chinese Academy of Medical Sciences, Cancer Hospital

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Cyclophosphamide; Doxorubicin; Prednisolone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Central Study Contacts

Chen Wang

CONTACT

(+86)18832374527; chen.wang@teruisipharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-06

Locations

CN (1)