Study of ATLCAR.CD138 Cells for Relapsed/Refractory Multiple Myeloma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

January 14, 2019

Primary Completion Date

October 16, 2024

Study Completion Date

August 18, 2039

Conditions
Multiple MyelomaImmune System Diseases
Interventions
DRUG

CAR138 T Cells

"The MTD is defined as the dose at which approximately 0.20 of subjects experience DLT dose escalation guided by the continual reassessment method (CRM).~Six dose levels will be evaluated:~Dose level 1: 5X10\^6 cells/m\^2 Dose level 2: 1X10\^7 cells/m\^2 Dose level 3: 2.5X10\^7 cells/m\^2 Dose level 4: 5X10\^7 cells/m\^2 Dose level 5: 1x10\^8 cells/m\^2 Dose level 6: 2x10\^8 cells/m\^2~Six subjects will be enrolled at the MTD to better characterize safety at that dose level.~Cell Administration: CAR138 T cells will be given by intravenous injection over through either a peripheral or a central line.~The lymphodepletion regimen will consist of intravenous cyclophosphamide 300 mg/m\^2 and fludarabine 30 mg/m\^2 given once daily for three days."

Trial Locations (1)

27599

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

All Listed Sponsors
collaborator

Baylor College of Medicine

OTHER

lead

UNC Lineberger Comprehensive Cancer Center

OTHER