A Phase 1 interventional study of CXCR4 modified anti-BCMA CAR T cells in Multiple Myeloma, sponsored by Sichuan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Sichuan University · Phase 1, Interventional, and Treatment
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 12 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CAR T cell therapy
Biological: CXCR4 modified anti-BCMA CAR T cells
intravenous infusion
Dose limiting toxicities (DLT)
Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
Time frame: 2 years
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 24 months
ORR (overall response rate)
Proportion of subjects with the best overall response (BOR)
Time frame: 3 months,6 months
CRR (complete response rate)
Proportion of subjects with the BOR of sCR+CR at Month 3
Time frame: 3 months
Plan to share: No
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Sichuan University