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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
Full description
This study will recruit LILRB4 positive 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.
Enrollment
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Inclusion criteria
Exclusion criteria
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;
Had a pulmonary embolism within 6 months prior to screening, or had a history of deep vein thrombosis of the lower extremities, or had active pulmonary disease and/or pneumonia, or had a history of interstitial lung disease;
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:
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.
Primary purpose
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Interventional model
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8 participants in 1 patient group
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Central trial contact
Gang An, Ph.D
Data sourced from clinicaltrials.gov
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