Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma
Purpose
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.
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Descartes-08 plus fludarabine/cyclophosphamide pretreat |
Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor |
|
More Details
- Status
- Completed
- Sponsor
- Cartesian Therapeutics