A Phase 1 interventional study of Descartes-08 and Fludarabine in Multiple Myeloma, sponsored by Cartesian Therapeutics. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Cartesian Therapeutics · Phase 1, Interventional, and Treatment
This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 32 is below the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Cartesian Therapeutics is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria (condensed):
NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary
Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
Biological: Descartes-08 · Drug: Fludarabine · Drug: Cyclophosphamide
autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
Also known as: CAR-T cells
intravenous fludarabine
intravenous cyclophosphamide
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence (number) of Treatment-Emergent Adverse Events \[Safety and Tolerability\]. Descriptive statistics by incidence rate, body system classification, severity, and causality \[per protocol definitions\]
Time frame: 2 weeks
Treatment response
IMWG treatment response criteria
Time frame: 1, 3, 6, 9 and 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Autologous Anti-BCMA-CAR-mRNA-transfected CD8+ T-lymphocytes · Fludarabine · Cyclophosphamide
Cartesian Therapeutics