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

First listed
Jul 23, 2025
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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