Health TrialsbyHealthPanel

GR1803 Injection in Patients With RRMM

ConditionMultiple Myleoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.

About this trial

All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be Complicated by Extramedullary Plasmacytoma.

Disqualifiers

1、Prior treatment with any BCMA-targeted therapy 2、Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、Known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.

Trial design

Design model

Single group

Treatments tested in this trial

  • GR1803

    Drug

    D1 given at a dose of 10ug/kg, D4 given at a dose of 30ug/kg, D8 given at a dose of 180ug/kg, followed by weekly dosing up to cycle 9, and cycle 10 and onwards, every 2 weeks, with a dosing cycle of every 4 weeks

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: GR1803Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR)

Time frame
2 years

Secondary outcomes

1

Progression-free survival (PFS)

Time from enrollment to tumor progression or death from any cause

Time frame
2 years
2

AE

adverse event

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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