NCT06574568

A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma

A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Excyte Biopharma Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to provide a basis for further clinical development of YKST02. YKST02 is a study medicine that targets multiple myeloma and activates the human body to fight against this disease.

Detailed description

This study is the first-in-human clinical trial to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary efficacy of YKST02 in patients with relapsed or refractory multiple myeloma (MM). Multiple Myeloma (MM) is a cancer of the blood's plasma cells (blood cell). YKST02 is a bispecific antibody bridging CD3-expressing T cells and BCMA-expressing multiple myeloma cells to induce T cells-mediated cytotoxicity. This study consists of dose escalation phase and dose expansion phase.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	YKST02	BCMA-CD3 bispecific antibody

Timeline

• Start date: 2024-06-14
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2024-08-28
• Last updated: 2026-02-05

Locations

12 sites across 1 country: China