Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
Study NCT ID:
NCT06574568
Status:
RECRUITING
Last Update Posted:
2024-09-25
First Post:
2024-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of YKST02 in Participants with Relapsed or Refractory Multiple Myeloma
Sponsor:
Excyte Biopharma Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: