Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma

Status:	Recruiting
Conditions:	Blood Cancer, Hematology, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	11/9/2018
Start Date:	February 26, 2018
End Date:	March 1, 2020
Contact:	Cartesian Coordinator for Clinical Trials
Email:	trials@cartesiantx.com
Phone:	302-648-6497

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

This Phase I 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.

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

- 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

- Prior allo-tranplant

We found this trial at

sites

Virgina Cancer Specialists

Fairfax, Virginia 22031

Principal Investigator: Gregory J. Orloff, MD

Phone: 571-389-0873

from

Fairfax, VA