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A Randomized, Open-Label, Multicenter Phase III Clinical Study of JS203 Plus Chemotherapy Versus Rituximab Plus Chemotherapy in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

ConditionDiffuse Large B-Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.

About this trial

This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (JS203-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age range: 18 to 75 years old (inclusive), both male and female are acceptable

ECOG: 0-1；

At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment；

Acceptable organ function at screening；

Disqualifiers

A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein)；

Previously received CD20-CD3 bispecific antibody treatment；

Previous allogeneic hematopoietic stem cell transplantation；

Previous solid organ transplantation

Trial design

Design model

Parallel

Treatments tested in this trial

  • JS203 in combination with gemcitabine and oxaliplatin

    Combination product

    gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W for up to 1 year

  • Rituximab in combination with gemcitabine and oxaliplatin

    Combination product

    Rituximab and gemcitabine and oxaliplatin 8 cycles (Q3W)

Treatment groups

282 Participants
are divided into 2 treatment groups
Group A: JS203+GemoxExperimental treatment 1 intervention
Group B: Rituximab+GemoxActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Overall survival (OS) evaluated based on 2014 Lugano criteria

Time frame
up to approximately 24 months

Secondary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR) based on 2014 Lugano criteria

Time frame
up to approximately 12 months
2

complete response (CR)

The complete response rate (CR) evaluated based on 2014 Lugano criteria

Time frame
up to approximately 12 months
3

Duration of response (DoR)

Duration of response (DoR) evaluated based on 2014 Lugano criteria

Time frame
up to approximately 12 months
4

Duration of complete response (DoCR)

Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria

Time frame
up to approximately 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Junshi Bioscience Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: