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Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma

NCT06829771 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-30

No results posted yet for this study

Summary

To explore the efficacy and safety of TQB2825 injection combined immunochemotherapy in subjects with untreated or R/R DLBCL.

The efficacy evaluation indicators are objective response rate (ORR), complete response rate (CR rate),progression free survival (PFS), duration of response (DOR) and overall survival(OS).

The safety evaluation indicators are dose-limiting toxicity (DLT) , maximum tolerated dose (MTD)and recommended phase II dose (RP2D).

Conditions

Interventions

DRUG

TQB2825 injection +R-CHOP regimen

R-CHOP is a cancer treatment regimen that uses a combination of five drugs to treat non-Hodgkin lymphoma, e.g., Rituximab+Cyclophosphamide+Doxorubicin Hydrochloride+Vincristine+Prednisone (R-CHOP). TQB2825 Injection: TQB2825 is a bispecific antibody targeting the cluster of differentiation 20 (CD20) receptor on tumor cells and the cluster of differentiation 3 (CD3) receptor on T cells. Rituximab: A monoclonal antibody that binds to the CD20 antigen on the surface of B cells. Cyclophosphamide: An alkylating agent that inhibits the synthesis of DNA and proteins in cancer cells. Doxorubicin Hydrochloride: An antineoplastic antibiotic that inhibits the synthesis of DNA and RNA. Vincristine: A microtubule inhibitor that blocks the normal function of microtubules during cell division. Prednisone: A corticosteroid drug with anti-inflammatory, anti-allergic, immunosuppressive, and anti-cancer effects. TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin)

DRUG

TQB2825 injection + GemOx

TQB2825 Injection: TQB2825 is a bispecific antibody targeting the CD20 receptor on tumor cells and the CD3 receptor on T cells. Gemcitabine: A nucleoside analog that inhibits DNA synthesis. Oxaliplatin: A platinum-based chemotherapy drug that forms cross-links with DNA, inhibiting DNA replication and transcription.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-23
Primary Completion
2026-05-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06829771 on ClinicalTrials.gov