Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06574568

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

Led by Excyte Biopharma Ltd · Updated on 2026-02-05

70

Participants Needed

12

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants or their legally acceptable representative must sign an informed consent form and agree to participate.
  • Diagnosis of multiple myeloma according to IMWG criteria.
  • Received at least two prior classes of drugs, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug.
  • Measurable disease at screening by serum M-protein ≥0.5 g/dL, urinary M-protein ≥200 mg/24 hours, or abnormal serum free light chain ratio with immunoglobulin FLC ≥10 mg/dL.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • Estimated survival time greater than 12 weeks.
  • Recovery to Grade 0-1 from prior therapy adverse events except alopecia.
  • Adequate blood and organ function.
  • Female participants of childbearing potential must have a negative pregnancy test and use effective contraception during and for 3 months after study treatment.
  • Male participants must use reliable contraception or abstain from sperm donation during and for 3 months after study treatment.
Not Eligible

You will not qualify if you...

  • Plasma cell leukemia, Waldenstrom's Macroglobulinemia, POEMS syndrome, or primary light-chain amyloidosis.
  • Recent antitumor therapy within specified washout periods including targeted therapy, chemotherapy, investigational drugs, or radiotherapy.
  • Autologous stem cell transplantation within 12 weeks or allogeneic stem cell transplantation within 6 months.
  • Prior treatment with BCMA-targeted therapies including CAR-T cells.
  • Active acute or chronic graft-versus-host disease requiring systemic treatment.
  • Prior myelodysplastic syndrome or other malignancies within 5 years except certain treated localized cancers.
  • Active central nervous system involvement or metastases.
  • Relevant CNS diseases or inflammatory brain lesions.
  • Significant cardiovascular diseases including recent acute coronary syndromes, unstable arrhythmias, severe heart failure, abnormal heart function, prolonged QTc interval, implantable defibrillator, or uncontrolled hypertension.
  • Known allergy to monoclonal antibodies or immunoglobulin.
  • Recent major surgery or trauma not recovered before treatment.
  • Recent systemic corticosteroid or immunosuppressive therapy.
  • Active hepatitis B, hepatitis C, or HIV infection.
  • Uncontrolled infections, pleural/pericardial effusion, or ascites requiring frequent drainage.
  • Pregnant or lactating women.
  • Mental disorders affecting compliance.
  • Recent live attenuated or live virus vaccination.
  • Other serious systemic diseases or lab abnormalities deemed inappropriate by investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Beijing Chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100024

Actively Recruiting

2

Beijing Jishuitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100035

Actively Recruiting

3

Shunde Hospital of Southern Medical University

Foshan, Guangdong, China, 528308

Actively Recruiting

4

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

5

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China, 510289

Not Yet Recruiting

6

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China, 530021

Not Yet Recruiting

7

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150081

Actively Recruiting

8

Henan Cancer Hospital

Zhengzhou, Henan, China, 450003

Not Yet Recruiting

9

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China, 116001

Actively Recruiting

10

Shandong Cancer Hospital

Jinan, Shandong, China, 250117

Not Yet Recruiting

11

Shanxi Cancer hospital

Taiyuan, Shanxi, China, 030013

Not Yet Recruiting

12

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

W

Wenming Chen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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