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