Immunotherapy has shown promise in the treatment of hematological malignancies, including multiple myeloma. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific cancer antigens. While CAR-NK therapy offers advantages over CAR-T therapy, such as reduced immune system reactions and lower production time and cost, challenges remain in terms of antitumor efficacy and the tumor microenvironment. Preclinical and early clinical studies have targeted various antigens, including BCMA, with CAR-NK cells in multiple myeloma. To further investigate the potential of BCMA-targeted CAR-NK cell therapy, this study aims to evaluate its safety and determine the maximum tolerated dose (MTD) in patients who have not responded to standard therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Ten eligible patients with relapsed refractory multiple myeloma will be enrolled based on inclusion criteria and informed consent. After conditioning with Fludarabine and Cyclophosphamide, patients will receive a single infusion of BCMA CAR NK cells with close monitoring using one of the following dose levels: * Dose Level 1: 1×10\^7/Kg * Dose Level 2: 5×10\^7/Kg * Dose Level 3: 1×10\^8/Kg Safety Assessment: Adverse events will be recorded and graded. Laboratory parameters and cytokine release syndrome (CRS) markers will be closely monitored. Efficacy Evaluation: Response assessments will follow IMWG guidelines, including complete response (CR), partial response (PR), stable disease (SD), and progressive disease.
Shariati Hospital
Tehran, Iran
Incidence of dose-limiting toxicity (DLTs)
Incidence of dose-limiting toxicity (DLTs) within 4 weeks after infusion, characterized by \>= Grade 3 signs/symptoms according to CTCAE v4.03, to assess safety and tolerability.
Time frame: 4 weeks
Assessment of Maximum Tolerated Dose (MTD)
Time frame: 4 weeks
Overall Remission Rate (ORR)
Overall Remission Rate (ORR) two months after infusion, assessed using International Myeloma Working Group (IMWG) criteria.
Time frame: 8 weeks
Progression-free survival (PFS)
Progression-free survival (PFS) for up to 12 months, assessed using IMWG criteria.
Time frame: 48 weeks
Duration of Response (DOR)
Duration of Response (DOR) for up to 12 months, assessed using IMWG criteria.
Time frame: 48 weeks
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