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Relapsed or Refractory Multiple MyelomaPhase 1NCT05011097

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

A Phase 1 study testing Y150 in people with Relapsed or Refractory Multiple Myeloma, run by Wuhan YZY Biopharma Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
Y150
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesChina
Study dates
8 Jul 2021to 25 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • ≥ 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)
  • Adequate hepatic function as evidenced by meeting all the following requirements:
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • Aspartate aminotransferase (AST), and alanine aminotransferase (ALT)≤ 2.5 × ULN;
  • Calculated creatinine clearance (CrCL) ≥ 30 mL/min
  • Understand and voluntarily sign written informed consent.

Who cannot join

  • 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.
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  • 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.
  • HIV antibody, TP antibody and HCV antibody were positive, HBsAg positive and hepatitis B virus DNA test showed that patients with active hepatitis B (HBV-DNA ≥ 1000cps/ml).
  • Patients who have received inoculation of (attenuated) live virus vaccine within 4 weeks before the first administration.
  • Pregnant, lactating women, or females or males who have fertility plan within 6 months during the study and after the end of the medication.
  • Patients with a previous history of definite neurological or psychiatric disorders, and investigator believe that it affects patients' cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.
  • Any condition that the investigator believes may not be appropriate for participating the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

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

    Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerability, PK/PD and Immunogenicity Characteristics of Recombinant Anti-CD38 and Anti-CD3 Bispecific Antibodies (Y150) for Injection in Patients With Relapsed or Refractory Multiple Myeloma

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.

Read the detailed description

This is a Phase I, open-label，dose-escalation trial in patients with relapsed or refractory multiple myeloma. There are two parts of the study: a dose-escalation part and a dose-expansion part. Dose escalation follows an accelerated design initially with 2 single subject cohorts (Cohorts 1-2) and switches to a classical 3+3 design (Cohorts 3-7). Dose-expansion means that at least 9 subjects (included subjects of the dose-escalation part) will be selected in 1 - 3 dose levels to focus on the pharmacokinetics (PK) / pharmacodynamic (PD) features and recommended dose for Phase II (RP2D). Additional purpose of the study is to find out whether the study drug has anti-tumor effects.

Being tested
Y150
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Y150Drug

    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.

Study groups in NCT05011097
Study groupRoleWhat they receive
Y150ExperimentalSubjects 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.
Receives: Drug: Y150

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to approximately 2 years

  2. 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.

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

Secondary outcomes (13)

  1. Area under the curve (AUC) of Y150

    Measured: Up to 1 weeks after the fourth dosing.

  2. Peak Plasma Concentration (Cmax) of Y150

    Measured: Up to 1 weeks after the fourth dosing.

  3. Half-time (t1/2) of Y150

    Measured: Up to 1 weeks after the fourth dosing.

  4. lymphocyte subsets in peripheral blood

    including CD3/CD4/CD8/CD14/CD19/CD38/CD45/CD56/CD69 lymphocyte subsets in peripheral blood

    Measured: 12 months (anticipated)

  5. Cytokines levels in serum

    including IL-2, IL-6, IL-8, IL-10, TNF-α, IFN-α, IFN-γ levels in serum

    Measured: 12 months (anticipated)

  6. Anti-drug antibodies(ADAs) titer

    Measured: 12 months (anticipated)

  7. neutralizing antibody titer

    Measured: 12 months (anticipated)

  8. Objective Response Rate (ORR)

    ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR), based on International Myeloma Working Group (IMWG) criteria.

    Measured: 12 months (anticipated)

  9. Time to Progression (TTP)

    TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression.

    Measured: 12 months (anticipated)

  10. Duration of Response

    Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.

    Measured: 12 months (anticipated)

  11. Progression-Free Survival (PFS)

    PFS was defined as the time between the date of first dose of Y150 and either disease progression or death, whichever occurs first.

    Measured: 12 months (anticipated)

  12. Overall Survival (OS)

    OS was defined as the number of days from administration of the first infusion (Day 1) to date of death.

    Measured: 12 months (anticipated)

  13. Time to first Response

    Time to first response was defined as the time from the date of first dose of Y150 to the date of initial documentation of a response (PR or better).

    Measured: 12 months (anticipated)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start8 Jul 2021
  3. Primary completion23 Oct 2023
  4. Study completion25 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05011097
Sponsor's protocol ID
Y15001
Status last verified
Jul 2025
First submitted
15 Jul 2021
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Y150 in people with Relapsed or Refractory Multiple Myeloma, run by Wuhan YZY Biopharma Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events according to CTCAE V5.0 (time frame: up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05011097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.

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