Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorExcyte Biopharma Ltd
About this trial
The goal of this Phase 2 clinical trial is to learn whether YKST02 is effective and safe in adults with relapsed or refractory multiple myeloma. The study will also evaluate how YKST02 is processed by the body (pharmacokinetics), how it affects the body (pharmacodynamics), and whether it causes the body to produce anti-drug antibodies.
The main questions it aims to answer are:
Does YKST02 demonstrate clinical efficacy in adults with relapsed or refractory multiple myeloma? What side effects occur during treatment with YKST02? What are the pharmacokinetic, pharmacodynamic, and immunogenicity characteristics of YKST02?
Participants will:
Complete screening assessments to determine whether they are eligible for the study.
Receive YKST02 by intravenous infusion according to the study treatment schedule.
Undergo regular assessments to evaluate treatment response and monitor safety. Provide blood and urine samples for pharmacokinetic, pharmacodynamic, and immunogenicity testing.
Complete follow-up visits after treatment discontinuation to monitor disease progression and survival.
Multiple myeloma is a cancer of plasma cells that remains incurable despite advances in treatment. Although currently available therapies can improve outcomes, most patients eventually experience disease relapse or become refractory to treatment.
YKST02 is an investigational humanized bispecific antibody targeting BCMA on myeloma cells and CD3 on T cells. Simultaneous binding to BCMA and CD3 may activate T cells and promote tumor cell killing.
This is a multicenter, open-label study consisting of two parts (Phase IIa and Phase IIb). In Phase IIa, participants will initially receive YKST02 at the starting dose level. Safety and efficacy data from this part of the study will be reviewed to determine the dose to be evaluated in Phase IIb.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
YKST02
DrugParticipants will receive YKST02 by intravenous infusion according to the protocol-defined treatment schedule. Treatment will continue until a protocol-defined treatment discontinuation criterion is met.
Treatment groups
64 Participants
are divided into 1 treatment groupGroup A: YKST02Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR)
Overall response rate (ORR), defined as the proportion of participants achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the investigator according to the 2016 International Myeloma Working Group (IMWG) response criteria.
Time frame
From first dose until disease progression or initiation of subsequent anti-cancer therapy, whichever occurs first (up to approximately 2 years).Secondary outcomes
1
Time to Response (TTR)
Time from the first dose of YKST02 to the first documented objective response (partial response or better) according to the 2016 International Myeloma Working Group (IMWG) response criteria.
Time frame
From first dose until first documented response (up to approximately 2 years)2
Progression-Free Survival (PFS)
Time from the date of the first dose of YKST02 to the first documented disease progression or death from any cause, whichever occurs first, according to the 2016 IMWG response criteria.
Time frame
From first dose until disease progression, death, or end of study (up to approximately 2 years)3
Duration of Response (DOR)
Time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first, according to the 2016 IMWG response criteria.
Time frame
From first documented response until disease progression, death, or end of study (up to approximately 2 years)4
Overall Survival (OS)
Time from the date of the first dose of YKST02 to death from any cause. Participants without documented death will be censored at the earlier of the last date known to be alive or the study cutoff date.
Time frame
From the date of first dose until death from any cause or study completionSponsors and contacts
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Source ClinicalTrials.gov
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