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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT06829771
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • TQB2825 injection +R-CHOP regimen — DRUG
    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)
  • TQB2825 injection + GemOx — DRUG
    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.

Study Details

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).

Key Dates

First listed
Feb 17, 2025
Start date
Apr 23, 2025
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TQB2825 injection +R-CHOP
    TQB2825 injection+R-CHOP (Rituximab+Cyclophosphamide+Doxorubicin Hydrochloride+Vincristine+Prednisone) TQB2825 injection,Rituximab,Cyclophosphamide,DoxorubicinHydrochloride,Vincristine,Prednisone,21 days as a treatment cycle.
  • Experimental: TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin)
    TQB2825 injection, Gemcitabine, Oxaliplatin, 21 days as a treatment cycle.

Primary Outcome Measure

Dose Limited Toxicity [ Time Frame: Baseline to up to two years ]

Central Contacts

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