This is a phase Ib/IIa, open-label, dose-escalation, and extension study to evaluate the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory multiple myeloma.
Age ≥18 years old, regardless of gender.
Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy.
Serum M protein ≥ 0.5g/dL (≥ 5 g/L); or
Urine M protein ≥ 200mg/24 hours; or
Known hypersensitivity to any of the ingredients of this product.
Diagnosis of active plasma cell leukemia.
Diagnosis of systemic light chain amyloidosis.
MM involving the central nervous system.
Sequential
STI-6129
Biological/VaccineAnti-CD38 A2 human antibody drug conjugate (ADC) containing an antibody covalently bound to a duostatin tubulin inhibitor.
Incidence of adverse events（AEs）
Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
Overall response rate（ORR）
ORR assessed by the modified IMWG response criteria.
Plasma concentration of the total anti-CD38 antibody
Determine plasma levels of the total antibody.
Plasma concentration of conjugated toxin
Determine plasma levels of conjugated toxin (STI 6129).
Plasma concentration of the free toxin
Determine plasma levels of the free toxin (duostatin 5.2).
Recommended Phase 2 dose (RP2D)
Determined according to the phase 1b.
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