Phase I Trial of GR1803 Injection in Patients With RRMM

Genrix (Shanghai) Biopharmaceutical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Myeloma (MM)

Treatments: Drug: GR1803 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07102706

GR1803-001

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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76 participants in 9 patient groups

0.02ug/kg GR1803

Experimental group

Treatment:

Drug: GR1803 injection

1ug/kg GR1803

Experimental group

Treatment:

Drug: GR1803 injection

10ug/kg GR1803

Experimental group

Treatment:

Drug: GR1803 injection

30ug/kg GR1803

Experimental group

Treatment:

Drug: GR1803 injection

90ug/kg GR1803

Experimental group

Treatment:

Drug: GR1803 injection

180ug/kg GR1803

Experimental group

Treatment:

Drug: GR1803 injection

240ug/kg GR1803

Experimental group

Treatment:

Drug: GR1803 injection

300ug/kg GR1803

Experimental group

Treatment:

Drug: GR1803 injection

360ug/kg GR1803

Experimental group

Treatment:

Drug: GR1803 injection