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New treatment option for Relapsed or Refractory Multiple Myeloma
Official title YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT05913804
What this study is testing
What is YTS104 Cells injection?
YTS104 Cells injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- Good organ function;
- ECOG score ≤1;
You likely can't join if
- 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...
- people 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)...
- Cerebrovascular accident (CVA) and transient ischemic attack (TIA);
See the full eligibility criteria
- 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...
- 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...
- Good organ function;
- ECOG score ≤1;
- The predicted survival time was ≥12 weeks;
- Female people of childbearing age or male people 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 people voluntarily participated in the study, signed the informed consent form, and complied with the follow-up.
- 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...
- people 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...
- Cerebrovascular accident (CVA) and transient ischemic attack (TIA);
- Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, etc.); d: people had uncontrolled hypertension (systolic blood pressure greater than 160...
- 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...
- 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...
- Patients with previous or concurrent uncured malignant tumors with unstable control, affecting the long-term survival of the people, excluding cured cervical carcinoma in situ, non-invasive basal cell or squamous cell...
- 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...
- 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;
- people had a history of mental illness, or substance abuse;
- people were pregnant or lactating;
- If participating in other treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.