Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma

NCT07695740 | Not Yet Recruiting Phase 2

• 1 other identifier: YKST02-Ⅱ-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Keywords

Relapsed or Refractory Multiple Myeloma; Bispecific Antibodies; YKST02; BCMA; CD3

Outcome Measures

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.

  From first dose until disease progression or initiation of subsequent anti-cancer therapy, whichever occurs first (up to approximately 2 years).

Secondary Outcomes (15)

• Time to Response (TTR)

  From first dose until first documented response (up to approximately 2 years)

• Progression-Free Survival (PFS)

  From first dose until disease progression, death, or end of study (up to approximately 2 years)

• Duration of Response (DOR)

  From first documented response until disease progression, death, or end of study (up to approximately 2 years)

• Overall Survival (OS)

  From the date of first dose until death from any cause or study completion

• Minimal Residual Disease (MRD) Negativity Rate

  From first dose through 28 days after the last dose (up to approximately 2 years)

Study Arms (1)

YKST02

EXPERIMENTAL

Drug: YKST02

Interventions

YKST02 DRUG

Participants 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.

YKST02

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Excyte Biopharma Ltd: lead

Study Sites (1)

Beijing Chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100024, China

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Wenming Chen, MD

CONTACT

+86-13910107759; 13910107759@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

CN (1)