MULTIPLE MYELOMA: Late-line: CAR-T cel study: BMT unit: DESCARTES-08

Phase I Safety and Feasibility Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma

Title
Cartesian DESCARTES-08 241-59-88 Myeloma
Study Title

Phase I Safety and Feasibility Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma

Site Link
Malignancy
Multiple Myeloma
Stage
Disease Setting
Relapsed/Refractory
Line Of Therapy
3rd or 4th
Investigational Agent
Descartes-08
Drug Class
CAR-T cell therapy (chimeric antigen receptor)
PI
Jason Chandler, MD
Sponsor
Cartesian Therapeutics
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Multiple myeloma either
    • 3rd line after failure of BOTH proteasome inhibitor and IMiD OR
    • 4th line regardless of prior therapies
  • Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, >5% bone marrow plasma cells.
  • No plasma cell leukemia
  • No CNS disease
  • No severe autoimmune diseas
  • No chronic pulmonary disease
  • ANC (>1000/uL), Pplatelet count (>50,000/uL), hemoglobin (>8 g/dL),
  • ALT and AST (each <3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (>30 mL/min),
  • Cardiac ejection fraction >45%
Objective

Primary-Safety

Secondary- Treatment response

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Multple myloma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X