A Phase I Clinical Trial of Y150 in the Treatment of Relapsed or Refractory Multiple Myeloma

NCT05011097 | Completed Phase 1

• 1 other identifier: Y15001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this Phase I study is to access the safety and tolerability of Y150 at different dose levels. It is hoped to find out the recommended dose for Phase II/III.

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events according to CTCAE V5.0

  An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  up to approximately 2 years

• Number of Participants With Dose Limiting Toxicities (DLTs)

  DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0.

  From the time of first dosing (Day 1) until the forth dosing (Day 28)

Secondary Outcomes (13)

• Area under the curve (AUC) of Y150

  Up to 1 weeks after the fourth dosing.

• Peak Plasma Concentration (Cmax) of Y150

  Up to 1 weeks after the fourth dosing.

• Half-time (t1/2) of Y150

  Up to 1 weeks after the fourth dosing.

• lymphocyte subsets in peripheral blood

  12 months (anticipated)

• Cytokines levels in serum

  12 months (anticipated)

Study Arms (1)

Y150

EXPERIMENTAL

Subjects who meet the enrollment criteria will enter the core treatment period and receive a cycle of treatment with Y150 (once weekly for 4 weeks) via intravenous infusion. And eligible subjects who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance.

Drug: Y150

Interventions

Y150 DRUG

Subjects will receive an intravenous infusion of Y150 in a dose escalation once a week for a 28-day treatment cycle until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Y150

Eligibility Criteria

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

You may qualify if:

• Male or female ≥ 18 years.
• Subject has a history of multiple myeloma with relapsed and refractory disease, and must have received at least 2 prior multiple myeloma treatment regimens (including a proteasome inhibitor and an immunomodulatory agent), or can not tolerate the toxicity of PIs and IMIDS; or have drug resistance to one and toxic intolerance to the other.
• Relapsed multiple myeloma is defined as IMWG criteria in 2016, including clinical relapse or relapse after CR.
• Refractory multiple myeloma is defined as failure of initial or salvage therapy to achieve at least a minimal response (only achieve SD after treatment ≥ 2 cycles ), or disease progression during treatment or within 60 days after the last treatment.
• Subjects must have measurable disease, including at least one of the criteria below:
• M-protein ≥ 10 g/L by SPEP/immunofixation for subjects with immunoglobulin class G (IgG) myeloma , M-protein ≥ 5g/L for subjects with IgA, IgD, IgE, IgM myeloma or
• ≥ 200 mg/24 hours urine collection by UPEP or
• Serum free light chain (FLC) levels ≥ 100 mg/L and an abnormal kappa/lambda (κ/λ) ratio in patients without detectable serum or urine M-protein
• The interval between the last anti-tumor treatment and the first administration of Y150 (including PIS and IMADs) ≥4 weeks, the interval between CD38 mAb administration and the first administration of Y150 ≥12 weeks;
• ECOG performance status 0 - 2;
• Life expectancy ≥ 3 months
• Adequate hematological function as evidenced by meeting all the following requirements:
• Absolute neutrophil count ≥1.0×109/L (growth factor support not allowed within 48h)
• Hemoglobin \> 70 g/L( without blood transfusion within 7 days)
• Platelet count ≥50×109/L(without transfusion within 7 days)

You may not qualify if:

• Subject has central nervous system involvement of multiple myeloma.
• Subject has received ≥ 10 mg/day prednisone equivalent within one week before starting Y150.
• Subject with primary or secondary plasma cell leukemia.
• Subject had a prior autologous stem cell transplant ≤ 12 weeks months prior to starting Y150, or had a prior autologous stem cell transplant history.
• Subject received a chimeric antigen receptor T (CAR T) cell product ≤ 6 months prior to starting Y150.
• Concurrent malignancy within 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer under active surveillance, prostate cancer that has undergone definitive treatment, ductal carcinoma in situ of the breast, or ≤ T1 urothelial carcinoma.
• Allergy to Abs drugs or human protein.
• Active infection(CTCAE Grade ≥2).
• Subjects with severe respiratory disease, and to be unsuitable to participate in study by investigators judgment.
• Severe cardiovascular disease, including a history of CABG or PCI, myocardial infarction within 6 months of study entry, unstable angina ,NYHA class III or IV heart failure, uncontrolled hypertension or left ventricular ejection fraction \<50%
• QTc interval \> 480 ms; Family or personal with a history of long or short QT syndrome; significant clinical history of ventricular arrhythmias, or currently receiving antiarrhythmic drugs or implanted defibrillator to treat ventricular arrhythmias.
• Patients with a history of active autoimmune diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.), except when the disease is in a stable state (without systemic immunosuppressant treatment, the symptoms are stable for more than 6 months).
• Patients with severe hyperthyroidism or hypothyroidism.
• Patients with metabolic diseases such as uncontrolled diabetes, severe gastrointestinal bleeding, severe diarrhea (Grade ≥ 2 according to CTCAE), or severe gastrointestinal obstruction requiring intervention.
• Patients with a history of immunodeficiency, including HIV positive.

Sponsors & Collaborators

• Wuhan YZY Biopharma Co., Ltd.: lead

Study Sites (2)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 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

Study Design

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

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 18, 2021
• Study Start: July 8, 2021
• Primary Completion: October 23, 2023
• Study Completion: June 25, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)