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

Recruiting now · Phase 1

Conditions studied: Relapsed or Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06574568

Run by

Excyte Biopharma Ltd

People needed

70

Starts

2024-06-14

Expected to finish

2027-06-30

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Diagnosis of multiple myeloma according to the IMWG criteria.
• 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.
• Measurable disease at screening, as defined by at least 1 of the following:
• Serum M-protein ≥0.5 g/dL;
• Urinary M-protein excretion ≥200 mg/24 hours;
• Abnormal serum free light chain (FLC) ratio ( <0.26 or >1.65) and serum immunoglobulin FLC≥10 mg/dL.
• Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1.
• An estimated survival time of more than 12 weeks.
• 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.
• Adequate hematological and organ function.
• 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.
• 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.

You may not qualify if…

• 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.
• History of antitumor therapy as follows, before the first dose of study drug:
• Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer;
• Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 2 weeks;
• Chemotherapy within 2 weeks;
• Treatment with an investigational drug within 2 weeks or 5 half-lives, whichever is shorter;
• 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;
• Autologous stem cell transplantation within 12 weeks;
• History of organ transplant, or allogeneic stem cell transplantation within 6 months;
• Prior treatment with any B cell maturation antigen (BCMA) targeted therapy;
• Prior treatment with any BCMA targeted chimeric antigen receptor modified [CAR]-T cells therapy.
• 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.
• 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.
• 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.
• (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.
• History or evidence of cardiovascular disease, including:
• Acute coronary syndromes (eg, myocardial infarction, unstable angina) within 6 months prior to enrollment;
• Coronary angioplasty or stenting within 6 months prior to enrollment;
• 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;
• 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;
• 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;
• The Fridericia-corrected QT interval (QTcF) ≥ 470 msec (female) or ≥ 450 msec (male)；
• Implantable defibrillator;
• Clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and/or DBP≥100 mm Hg).
• Known allergy to monoclonal antibody drugs or exogenous immunoglobulin.

Where it is running

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

Full record on ClinicalTrials.gov

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