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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma (NCT06574568) is a Phase 1 interventional studying Relapsed or Refractory Multiple Myeloma, sponsored by Excyte Biopharma Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Relapsed or Refractory Multiple Myeloma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 70 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Relapsed or Refractory Multiple Myeloma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study. 2. Diagnosis of multiple myeloma according to the IMWG criteria. 3. Receipt of at least two prior classes of drugs either in separate regimens or as combinations. The three classes are defined as: An immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug. 4. Measurable disease at screening, as defined by at least 1 of the following: 1. Serum M-protein ≥0.5 g/dL; 2. Urinary M-protein excretion ≥200 mg/24 hours; 3. Abnormal serum free light chain (FLC) ratio ( \<0.26 or \>1.65) and serum immunoglobulin FLC≥10 mg/dL. 5. Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1. 6. An estimated survival time of more than 12 weeks. 7. Recovery to Grade 0-1 (Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0) from adverse events related to prior therapy except alopecia. 8. Adequate hematological and organ function. 9. Female participants of childbearing potential must have a negative serum pregnancy test at screening. Female patients who are sexually active must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment. 10. Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 3 months after the last dose. Who Should NOT Join This Trial: 1. Plasma cell leukemia (\>2.0×10\^9/L plasma cells by standard differential), Waldenstrom's Macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary light-chain amyloidosis. 2. History of antitumor therapy as follows, before the first dose of study drug: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study. 2. Diagnosis of multiple myeloma according to the IMWG criteria. 3. Receipt of at least two prior classes of drugs either in separate regimens or as combinations. The three classes are defined as: An immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug. 4. Measurable disease at screening, as defined by at least 1 of the following: 1. Serum M-protein ≥0.5 g/dL; 2. Urinary M-protein excretion ≥200 mg/24 hours; 3. Abnormal serum free light chain (FLC) ratio ( \<0.26 or \>1.65) and serum immunoglobulin FLC≥10 mg/dL. 5. Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1. 6. An estimated survival time of more than 12 weeks. 7. Recovery to Grade 0-1 (Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0) from adverse events related to prior therapy except alopecia. 8. Adequate hematological and organ function. 9. Female participants of childbearing potential must have a negative serum pregnancy test at screening. Female patients who are sexually active must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment. 10. Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 3 months after the last dose. Exclusion Criteria: 1. Plasma cell leukemia (\>2.0×10\^9/L plasma cells by standard differential), Waldenstrom's Macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary light-chain amyloidosis. 2. History of antitumor therapy as follows, before the first dose of study drug: 1. Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer; 2. Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 2 weeks; 3. Chemotherapy within 2 weeks; 4. Treatment with an investigational drug within 2 weeks or 5 half-lives, whichever is shorter; 5. Radical/extensive radiotherapy within 4 weeks, or local palliative radiotherapy within 2 weeks, or acute toxicity induced by previous radiotherapy have not recovered to grade ≤1; 6. Autologous stem cell transplantation within 12 weeks; 7. History of organ transplant, or allogeneic stem cell transplantation within 6 months; 8. Prior treatment with any B cell maturation antigen (BCMA) targeted therapy; 9. Prior treatment with any BCMA targeted chimeric antigen receptor modified \[CAR\]-T cells therapy. 3. Any active acute graft-versus-host disease (GvHD), grade 2-4 (according to Glucksberg criteria) or active chronic GvHD requiring systemic treatment within 2 weeks. 4. Prior myelodysplastic syndrome or malignancy within 5 years, except for localized malignancies that have been adequately treated or free of the disease for ≥ 5 years, e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast. 5. Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the investigator. 6. (a) History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis; (b) Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI. 7. History or evidence of cardiovascular disease, including: 1. Acute coronary syndromes (eg, myocardial infarction, unstable angina) within 6 months prior to enrollment; 2. Coronary angioplasty or stenting within 6 months prior to enrollment; 3. Clinically significant unstable arrhythmias (eg, atrial fibrillation), however, atrial fibrillation has been controlled for over 30 days prior to the first dose of YKST02 were allowed; 4. New York Heart Association (NYHA) stage III or higher congestive heart failure within 6 months prior to enrollment; Cardiac valve morphological abnormalities recorded by ECHO (≥ grade 2), note that grade 1 cardiac valve morphological abnormalities (such as mild regurgitation/stenosis) were allowed, but participants with moderate valve thickening were excluded; 5. Left ventricular ejection fraction (LVEF) below lower limit of the study center, or LVEF\<50% if there is no lower limit at the study center; 6. The Fridericia-corrected QT interval (QTcF) ≥ 470 msec (female) or ≥ 450 msec (male); 7. Implantable defibrillator; 8. Clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and/or DBP≥100 mm Hg). 8. Known allergy to monoclonal antibody drugs or exogenous immunoglobulin. 9. Any major organ surgery or significant trauma within 4 weeks prior to the first dose of YKST02, or those requiring elective surgeries during the study, and all AEs associated with surgery or significant trauma have not recovered before the first dose of the YKST02. 10. Regular dose of systemic corticosteroids during 4 weeks prior to initiation of study drug, or anticipated need of corticosteroids exceeding prednisone 20 mg/day or equivalent during the trial, or any other systemic immunosuppressive therapy within 4 weeks prior to study entry. 11. Virological tests: Hepatitis B virus surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) quantitative \>ULN of the testing institution; Hepatitis C antibody (HCV-Ab) positive and hepatitis C virus-RNA (HCV-RNA) quantitative \> ULN of the testing institution; Anti-human immunodeficiency virus (Anti-HIV) positive. Participants will be excluded from the study if any of the above criteria is met. 12. Uncontrolled active infections requiring oral or intravenous systemic therapy, except for local treatment. 13. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently). 14. Pregnant or lactating women. 15. Known mental disorder that may affect study compliance or poor compliance. 16. Receipt of any live attenuated vaccines or live virus vaccine within 4 weeks prior to the first dose of study treatment. 17. Other serious systemic diseases or laboratory abnormalities or other reasons that the investigator believes are not appropriate for participating the study.

Treatments Being Tested

DRUG

YKST02

BCMA-CD3 bispecific antibody

Locations (12)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanxi Cancer hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06574568), the sponsor (Excyte Biopharma Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06574568 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06574568?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06574568?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06574568. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06574568. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.