JS203 Combination Regimens in B-Cell Non-Hodgkin's Lymphoma

Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Study ID
NCT07081022
Phase
PHASE2
Status
Recruiting
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Conditions

  • B-cell Non-Hodgkin's Lymphoma

Eligibility Criteria

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

Interventions

  • JS203 in combination with gemcitabine and oxaliplatin — DRUG
    Gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W until progression or unacceptable toxicity.
  • JS203 in combination with ifosfamide, carboplatin and etoposide — DRUG
    Ifosfamide, carboplatin and etoposide, 3 cycles (Q3W) and JS203, Cycle 1 QW, Cycle 2 and therafter Q3W until trasnplant, progression or unacceptable toxicity.
  • JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone — DRUG
    Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone 6 cycles (Q3W) and JS203, 8 cycles (21 days/cycle), Cycle 1 QW, Cycle 2 to Cycle 8 Q3W.
  • JS203 combined with lenalidomide — DRUG
    lenalidomide,12 cycles, Cycle 1(Q3W), Cycle 2 to Cycle 12 (Q4W) and JS203, 12 cycles, Cycle 1 (21 days/cycle) QW, Cycle 2 to Cycle 12 (28 days/cycle) Q4W.

Study Details

To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma

Key Dates

Start date
Aug 17, 2025
Status verified
Jul 2025
Primary completion
Apr 6, 2027
Completion
Apr 6, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DLBCL-Gemox
    In participants with relapsed/refractory diffuse large B cell lymphoma ineligible for ASCT
  • Experimental: DLBCL-ICE
    In participants with relapsed/refractory diffuse large B cell lymphoma intended for ASCT
  • Experimental: DLBCL- RCHOP
    In participants with newly diagnosed diffuse large B cell lymphoma
  • Experimental: FL-Lena
    In participants with relapsed/refractory follicular lymphoma
  • Experimental: MCL-Lena
    In participants with relapsed/refractory mantle cell lymphoma
  • Experimental: MZL-Lena
    In participants with relapsed/refractory marginal zone lymphoma

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: up to approximately 15 months ]

Central Contacts

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