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New treatment option for Relapsed or Refractory Multiple Myeloma
Official title A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06574568
What this study is testing
What is YKST02?
YKST02 is an investigational medicine, being studied as a potential treatment for relapsed or refractory multiple myeloma.
Also referred to as YKST02 for Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures...
- 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...
- Measurable disease at screening, as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL;
You likely can't join if
- Plasma cell leukemia (\>2.0×10\^9/L plasma cells by standard differential), Waldenstrom's Macroglobulinemia, POEMS syndrome (polyneuropathy...
- 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;
See the full eligibility criteria
Who can join
- 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 ( \ 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- (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...
- 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...
- 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.
- 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...
- 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...
- 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...
- Uncontrolled active infections requiring oral or intravenous systemic therapy, except for local treatment.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).
- Pregnant or lactating women.
- Known mental disorder that may affect study compliance or poor compliance.
- Receipt of any live attenuated vaccines or live virus vaccine within 4 weeks prior to the first dose of study treatment.
- Other serious systemic diseases or laboratory abnormalities or other reasons that the investigator believes are not appropriate for participating the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Foshan, Guangdong, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Dalian, Liaoning, China
- Jinan, Shandong, China
- Taiyuan, Shanxi, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Foshan, Guangdong, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Harbin, Heilongjiang, China; Zhengzhou, Henan, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.