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Relapsed or Refractory Multiple MyelomaPhase 1NCT05913804

YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing YTS104 Cells injection in people with Relapsed or Refractory Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of relapsed or refractory multiple myeloma subjects Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
YTS104 Cells injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
28 Jun 2023to 30 Dec 2025
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-75 years, gender is not limited;
  • Patients diagnosed as relapsed/refractory multiple myeloma according to the International Myeloma Working Group (IMWG 2014) criteria for multiple myeloma after at least 3 lines of treatment (including at least one proteasome inhibitor and an immunomodulator based chemotherapy regimen), and at least one complete treatment cycle per line of treatment; Documented disease progression during or within 12 months after the most recent antimyeloma therapy (not limited to 12 months after CAR-T therapy as the last line of therapy);
  • The presence of one or more measurable lesions at screening was defined as any of the following: 1) serum M-protein ≥0.5g/dL (≥5g/L), 2) urinary M-protein level ≥200 mg/24 hours; 3) serum free light chain (sFLC) ≥100 mg/L and serum κ/λ free light chain ratio abnormal (<0.26 or >1.65);
  • Good organ function;
  • ECOG score ≤1;
  • The predicted survival time was ≥12 weeks;
  • Female subjects of childbearing age or male subjects with partners of women of childbearing age agreed to use effective methods of contraception throughout the trial and for 12 months after cell infusion;
  • The subjects voluntarily participated in the study, signed the informed consent form, and complied with the follow-up.

Who cannot join

  • A history of allergy to any component of the cell product;
  • Patients who had used CAR-T cell therapy or any other gene transduction or other therapeutic products within 3 months after signing the informed consent, except those with undetectable CAR-T cells or CAR-T cells below the lower limit of detection;
  • Subjects had plasma cell leukemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary light chain amyloidosis;
  • Patients with a history of any of the following cardiovascular and cerebrovascular diseases within the preceding 6 months were screened;
  • Congestive heart failure (New York Heart Association [NYHA]≥III), congenital long QT syndrome, left front half block (double bundle block), asymptomatic right bundle branch block allowed; Myocardial infarction, unstable angina pectoris, coronary angioplasty, stent implantation, coronary/peripheral artery bypass grafting;
  • Cerebrovascular accident (CVA) and transient ischemic attack (TIA);
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  • Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, etc.); d: Subjects had uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg), a history of hypertensive crisis, or hypertensive encephalopathy;
  • Pulmonary embolism, or deep venous thrombosis of the lower extremity requiring anticoagulation, or active lung disease and/or pneumonia have occurred within 6 months prior to screening;
  • Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) and HBV DNA in peripheral blood were positive. Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Treponema pallidum antibody was positive;
  • Patients with known systemic lupus erythematosus, co-active or uncontrolled autoimmune diseases (e.g., Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immunodeficiency (e.g., HIV infection or severe infectious diseases);
  • Patients with previous or concurrent uncured malignant tumors with unstable control, affecting the long-term survival of the subjects, excluding cured cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, or other malignant tumors with local prostate cancer after radical treatment, ductal carcinoma in situ after radical treatment and no recurrence for at least 5 years;
  • Patients with current or previous history of central nervous system disease, such as seizures, stroke, severe brain injury, aphasia, paralysis, dementia, Parkinson's disease, mental illness, etc.;
  • Have central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial neuropathy and extensive lesions or spinal cord compression);
  • Patients had undergone previous solid-organ transplantation or allogeneic hematopoietic stem-cell transplantation (allo-HSCT) 6 months before screening or autologous stem-cell transplantation within 3 months before apheresis;
  • Patients with acute or chronic graft-versus-host disease (GVHD) at screening time;
  • The following anti-MM treatments were used at the indicated times prior to apheresis:
  • Use of any immunosuppressant or radiotherapy within 2 weeks prior to apheresis;
  • Received cytotoxic or proteasome inhibitors or small-molecule targeted therapy within 2 weeks of preapheresis or 3 half-lives, whichever is shorter;
  • Received any macromolecular therapy such as monoclonal antibodies within 4 weeks prior to anapheresis or within 3 half-lives, whichever is shorter;
  • Received immunomodulator within 1 week;
  • The patient had a history of live vaccination within 4 weeks before signing ICF;
  • Subjects had a history of mental illness, or substance abuse;
  • Subjects were pregnant or lactating;
  • If participating in other interventional clinical studies before apheresis, the requirements of drug washout before apheresis should be met;
  • The investigator believes that there are other factors unsuitable for inclusion or affecting participants' participation in or completion of the study.

Trial locations and contacts

1 site in 1 country.

Gang An, Ph.D contact

13502181109

angang@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin

    Lugui Qiu, 0086-022-23909171, qiulg@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study on the Safety and Efficacy of YTS104 Cell Injection in the Treatment of Relapsed or Refractory Multiple Myeloma

This is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of relapsed or refractory multiple myeloma subjects

Read the detailed description

This study will recruit multiple myeloma subjects,and Subjects should undergo FC chemotherapy before returning the cells, then followed by infusion of YTS104 cells injection. YTS104 cells injection will be intravenously infused with a escalated dose of 1E6#3E6#6E6#1E7 cells/kg.

Being tested
YTS104 Cells injection
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.

  • YTS104 Cells injectionBiological

    YTS104 Cell injection(LILRB4 dual STAR-T Cell Injection/BCMA LILRB4 Dual STAR-T Cell Injection)) is a new STAR-T cell transfected by lentivirus.The study required that lymphocytes were collected from the subjects and cultured for 2-3 weeks to obtain YTS104 cell injection. Subjects were treated with fludarabine and cyclophosphamide chemotherapy prior to reinfusion, followed by a 2-day rest period before cell infusion.

Study groups in NCT05913804
Study groupRoleWhat they receive
YTS104 cells injectionExperimentalSubjects will receive cell infusion, with the initial cell dose of 1E6/kg. 1-6 subjects will be enrolled. The second dose group was 3E6 cells /kg with 1-6 subjects; The third and fourth dose groups were 6E6 cells /kg and 1E7 cells /kg, respectively, with 3-6 subjects.Subjects may undergo secondary or multiple retransfusion
Receives: Biological: YTS104 Cells injection

What is being measured

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

  1. Number of Patients with Dose Limiting Toxicity

    Dose-limiting toxicity was defined as adverse events associated with YTS104-cell injection within 28 days of cell transfusion, including grade 4 or 5 CRS and ICANS; grade 4 haematological adverse events did not return to grade 2 or baseline within 28 days of cell transfusion

    Measured: Within 28 days after cell transfusion

  2. Incidence and severity of adverse events

    After YTS104-cell infusion, adverse events will be graded as CTCAE 5.0

    Measured: 24 months

Secondary outcomes (5)

  1. Overall response rate (ORR)

    Including sCR, CR, VGPR, and PR.

    Measured: 24 months

  2. Duration OF RESPONSE(DOR)

    DOR was defined as the time from the first documentation of response (PR or better) to the first documentation of disease progression or death from any cause after YTS104 infusion in patients with PR or better.

    Measured: 24 months

  3. Progression-free survival(PFS)

    PFS was defined as the time between the subject's YTS104-cell infusion and the occurrence of disease progression or death from any cause.

    Measured: 24 months

  4. Overall survival(OS)

    It was defined as the time between the subject's reinfusion of YTS104 cell injection and death from any cause.

    Measured: 24 months

  5. Expansion and persistence of YTS104 cell injection in vivo

    The proportion of STAR-T in peripheral blood was detected by flow cytometry,The copies of STAR-T DNA in peripheral blood was detected by qPCR method.

    Measured: 24 months

Timeline

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

  1. First posted22 Jun 2023
  2. Study start28 Jun 2023
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

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
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05913804
Sponsor's protocol ID
IIT2023020
Status last verified
Sep 2024
First submitted
11 May 2023
Last updated
15 Aug 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 YTS104 Cells injection in people with Relapsed or Refractory Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site 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 8 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Gang An, Ph.D (13502181109, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients with Dose Limiting Toxicity (time frame: Within 28 days after cell transfusion). 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 NCT05913804.

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 15 Aug 2025.

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