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

NCT06574568 | Recruiting Phase 1

• 1 other identifier: YKST02-I-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Dose-limiting Toxicities (DLT)

  The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.

  21 days after the first dose

• Incidence of Adverse Events (AEs)

  An AE is defined as any untoward medical event that occurs after a subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.

  up to 42 weeks

• Incidence of Serious Adverse Events (SAEs)

  A SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the subject receives the investigational drug, and congenital abnormalities or birth defects.

  up to 42 weeks

• Overall Response Rate (ORR)

  Measured by IMWG criteria, only applicable in dose expansion phase

  From the date of dosing until the date of first documented progression

Secondary Outcomes (9)

• Area under the Concentration-time Curve (AUC) after Administration

  up to 42 weeks

• Maximum Serum Concentration (Cmax) of YKST02

  up to 42 weeks

• Time to Cmax of YKST02 (Tmax)

  up to 42 weeks

• Terminal Half-life (T1/2) of YKST02

  up to 42 weeks

• Percentage of Participants with Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) Against YKST02

  up to 42 weeks

Study Arms (1)

YKST02

EXPERIMENTAL

Participants will receive different doses of YKST02 in 21-day cycles via intravenous injection.

Drug: YKST02

Interventions

YKST02 DRUG

BCMA-CD3 bispecific antibody

Also known as: YKST02 for Injection

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:

• 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.

Sponsors & Collaborators

• Excyte Biopharma Ltd: lead

Study Sites (12)

Beijing Chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100024, China

RECRUITING

Beijing Jishuitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100035, China

RECRUITING

Shunde Hospital of Southern Medical University

Foshan, Guangdong, 528308, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510289, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Shanxi Cancer hospital

Taiyuan, Shanxi, 030013, China

NOT YET RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

Injections

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Wenming Chen, MD

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenming Chen, MD

CONTACT

+86-13910107759; 13910107759@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CN (12)