New antibody drug aims to outsmart Treatment-Resistant myeloma
NCT ID NCT07695740
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This phase 2 trial tests an investigational drug called YKST02 in adults with multiple myeloma that has relapsed or stopped responding to prior treatments. YKST02 is a bispecific antibody designed to bind both myeloma cells and immune T cells, potentially helping the immune system destroy the cancer. The study will measure how well the drug shrinks tumors, monitor side effects, and examine how the body processes the medication. About 64 participants will receive YKST02 by intravenous infusion and undergo regular assessments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- YKST02 (a bispecific antibody that targets myeloma cells and activates immune T cells)
- What this could lead to
- If successful, YKST02 could offer a new treatment option for people with multiple myeloma whose cancer has returned or stopped responding to other therapies.
- What could go wrong
- This is an early-phase trial with only 64 participants, so results may not apply to all patients. Side effects, including immune reactions, are possible and not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able and willing to provide written informed consent (or consent provided by a legally authorized representative, where applicable) and comply with all study procedures. * Diagnosis of multiple myeloma according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria. * Relapsed or refractory multiple myeloma after at least two prior lines of therapy, including prior exposure to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. * Measurable disease as defined in the study protocol. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Estimated life expectancy of at least 12 weeks. * Recovery from clinically significant toxicities related to prior anticancer therapy to an acceptable level before study treatment (except alopecia). * Adequate hematologic, hepatic, renal, and coagulation function based on protocol-specified laboratory criteria. * Women of childbearing potential must have a negative pregnancy test before study treatment and agree to use effective contraception during the study and for 3 months after the last dose of study treatment. * Male participants must agree to use effective contraception during the study and for 3 months after the last dose of study treatment and must not donate sperm during this period. Exclusion Criteria: * Plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light-chain (AL) amyloidosis. * Prior treatment with any BCMA-targeted therapy, including BCMA-directed chimeric antigen receptor (CAR) T-cell therapy. * Recent anticancer therapy, investigational medicinal product, radiotherapy, stem cell transplantation, or organ transplantation that does not meet the protocol-defined washout requirements. * Active graft-versus-host disease (GvHD) requiring systemic treatment or clinically significant active GvHD. * History of another malignancy within the past 5 years, except for adequately treated malignancies with negligible risk of recurrence, as specified in the protocol. * Symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or evidence of uncontrolled CNS or leptomeningeal involvement that, in the investigator's judgment, makes the participant unsuitable for study participation. * History of clinically significant central nervous system disorders that may increase study risk or interfere with study participation. * Clinically significant cardiovascular disease, including recent acute coronary syndrome or coronary revascularization, uncontrolled arrhythmias, New York Heart Association (NYHA) Class III or IV heart failure, clinically significant cardiac dysfunction, prolonged QT interval, or uncontrolled hypertension. * Known hypersensitivity to monoclonal antibodies, human immunoglobulins, or any component of the study drug. * Major surgery or severe trauma shortly before study treatment, or planned major surgery during the study. * Requirement for systemic corticosteroids or other immunosuppressive therapy for conditions other than multiple myeloma that does not meet protocol requirements. * Active hepatitis B or hepatitis C infection, positive human immunodeficiency virus (HIV) test, or other clinically significant uncontrolled infection requiring systemic therapy. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. * Pregnant or breastfeeding women. * Known psychiatric illness or other conditions that may compromise the participant's ability to comply with study requirements. * Receipt of a live or live attenuated vaccine within the protocol-defined period before the first dose of study treatment. * Any other clinically significant medical condition, laboratory abnormality, or circumstance that, in the investigator's judgment, would make participation in the study inappropriate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100024, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists test CAR-T cells made inside the body to fight Hard-to-Treat myeloma
- New hope for Tough-to-Treat blood cancer: phase 3 trial launched
- New Three-Drug cocktail aims to tackle Hard-to-Treat multiple myeloma
- Double-Barreled CAR-T cells take aim at Hard-to-Treat myeloma
- Double-Barreled CAR-T attack on Hard-to-Treat myeloma
- New antibody drug tested for tough blood cancers – but trial stopped early