AzTrials
AzTrials

Diffuse Large B-Cell Lymphoma (DLBCL)Phase 1/2NCT07035379

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

A Phase 1/2 study testing TRS005, Cyclophosphamide and Doxorubicin in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Zhejiang Teruisi Pharmaceutical Inc. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma (DLBCL)
What is being tested?
TRS005, Cyclophosphamide and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
1 Sep 2025to 1 Sep 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chen Wang contact

(+86)18832374527

chen.wang@teruisipharm.com

China1 site

  • Chinese Academy of Medical Sciences, Cancer Hospital

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official 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

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.

Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRS005Drug

    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).

  • CyclophosphamideDrug

    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.

  • DoxorubicinDrug

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

  • PrednisoloneDrug

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

Study groups in NCT07035379
Study groupRoleWhat they receive
TRS005+CHPExperimentalTRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone（T-CHP）
Receives: Drug: TRS005; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

    Measured: Day 1 up to approximately 6 months

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

    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

    Measured: At the end of treatment (Month 6)

  2. Duration of Response (DOR)

    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.

    Measured: Up to 24 months

  3. Progression-Free Survival (PFS)

    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.

    Measured: Up to 24 months

  4. Overall Survival (OS)

    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.

    Measured: Up to 24 months

  5. Immunogenicity

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

    Measured: At the end of treatment (Month 6)

  6. Serum concentration

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07035379
Sponsor's protocol ID
TRS00501003
Status last verified
Jun 2025
First submitted
13 Jun 2025
Last updated
22 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TRS005, Cyclophosphamide and Doxorubicin in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Zhejiang Teruisi Pharmaceutical Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chen Wang ((+86)18832374527, chen.wang@teruisipharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part I: Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD) (time frame: Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07035379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in