West Cancer Center

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

NCT03448978

Malignancy

Multiple Myeloma

Stage

Stage 4

Disease Setting

Relapsed/Refractory

Line Of Therapy

3rd or 4th

Investigational Agent

Descartes-08

Drug Class

CAR-T cell therapy (chimeric antigen receptor)

Jason Chandler, MD

Sponsor

Cartesian Therapeutics

Phase

Phase 1

Status

Closed to Accrual

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

Assessment Frequency Link

Path

Multple myloma

Dosing Frequency

Control Agents

Study Protocol

Randomized