Health TrialsbyHealthPanel

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

ConditionB-cell Non-Hodgkin's Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Junshi Bioscience Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age range: 18 to 80 years old (inclusive), both male and female are acceptable；

ECOG: 0-2；

B-cell non-Hodgkin's lymphoma expressing CD20 antigen that has been pathologically diagnosed；

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

    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.

Treatment groups

180 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: DLBCL-GemoxExperimental treatment 1 intervention
Group B: DLBCL-ICEExperimental treatment 1 intervention
Group C: DLBCL- RCHOPExperimental treatment 1 intervention
Group D: FL-LenaExperimental treatment 1 intervention
Group E: MCL-LenaExperimental treatment 1 intervention
Group F: MZL-LenaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR) based on 2014 Lugano criteria

Time frame
up to approximately 15 months

Secondary outcomes

1

complete response (CR)

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

Time frame
up to approximately 24 months
2

Duration of response (DoR)

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

Time frame
up to approximately 24 months
3

Duration of complete response (DoCR)

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

Time frame
up to approximately 24 months
4

Time to response (TTR)

Time to response (TTR) evaluated based on 2014 Lugano criteria

Time frame
up to approximately 24 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
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