Evaluation of the Efficacy and Safety of TQB2825 Injection Compared to Immunotherapy in the Treatment of Recurrent/Refractory Follicular Lymphoma

Sponsor
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Study ID
NCT07187960
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • TQB2825 Injection — DRUG
    TQB2825 is a Cluster of Differentiation 3 (CD3) × Cluster of Differentiation 20 (CD20) bispecific antibody.
  • Rituximab Injection — DRUG
    Rituximab combined with Chemotherapy (Rituximab, Cyclophosphamide, doxorubicin, Vincristine, Prednisone, Ifosfamide, Gemcitabine, cisplatin, Carboplatin, Etoposide, MESNA, Dexamethasone)

Study Details

Evaluation of the efficacy and safety of TQB2825 injection compared to immunotherapy in the treatment of recurrent/refractory follicular lymphoma.

Key Dates

Start date
Nov 30, 2025
Status verified
Mar 2025
Primary completion
Oct 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TQB2825 Injection
    TQB2825 single drug intravenous injection, 28 days as a treatment cycle.
  • Active Comparator: Rituximab Injection
    Rituximab combined with Chemotherapy regimen, 21 days as a treatment cycle.

Primary Outcome Measure

Progression free survival (PFS) evaluated by an independent review committee (IRC) [ Time Frame: 2 years ]

Central Contacts

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