Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang ACEA Pharmaceutical Co. Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • STI-6129

Treatment groups

84 Participants
are divided into 1 treatment group