Description:
This Phase I/II 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.
This Phase I/II 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.
Recruiting
Phase 1/Phase 2
Drug | Synonyms | Arms |
---|---|---|
Descartes-08 | CAR-T cells | Descartes-08 plus fludarabine/cyclophosphamide pretreat |
Fludarabine | Descartes-08 plus fludarabine/cyclophosphamide pretreat | |
Cyclophosphamide | Descartes-08 plus fludarabine/cyclophosphamide pretreat |
Name | Type | Description | Interventions |
---|---|---|---|
Descartes-08 plus fludarabine/cyclophosphamide pretreat | Experimental | Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor |
|
Inclusion Criteria (condensed): - Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy - Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, >5% bone marrow plasma cells. - Adequate vital organ function as indicated by ANC (>1000/uL), platelet count (>50,000/uL), hemoglobin (>8 g/dL), serum ALT and AST (each <3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (>30 mL/min), and cardiac ejection fraction (>45%) Exclusion Criteria (condensed): NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary - Active plasma cell leukemia - Pregnant or lactating - Active, uncontrolled infection - Active and severe auto-immune disease - Active arrhythmia, or obstructive or restrictive pulmonary disease - Central nervous system disease
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability] |
Time Frame: | 2 weeks |
Safety Issue: | |
Description: | Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]. Descriptive statistics by incidence rate, body system classification, severity, and causality [per protocol definitions] |
Measure: | Treatment response |
Time Frame: | 1, 3, 6, 9 and 12 months |
Safety Issue: | |
Description: | IMWG treatment response criteria |
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Cartesian Therapeutics |
February 10, 2021