Phase I Trial of GR1803 Injection in Patients With RRMM

Genrix (Shanghai) Biopharmaceutical Co., Ltd.76 enrolled

Overview

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 52 weeks or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma (MM)

Interventions

GR1803 injectionDRUG

weekly dose up to week 24 , biweekly dose from week 24 to week 36, and triweekly dose from week 36 to week 52

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ECOG score 0-2. * ≥18 years of age. * Multiple myeloma must be measurable by central laboratory assessment: Serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio. Exclusion Criteria: * Prior treatment with any BCMA-targeted therapy. * Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. * Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

DLT

Dose Limited Toxicity

Time frame: 52 weeks

Secondary Outcomes

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: 52 weeks

Progression-free survival (PFS)

Time from enrollment to tumor progression or death from any cause

Time frame: 52 weeks

Data from ClinicalTrials.gov

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