Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN.

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

February 17, 2020

Primary Completion Date

May 17, 2023

Study Completion Date

May 17, 2023

Conditions
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Interventions
BIOLOGICAL

MB-102

"The study drug, MB-102 consists of adoptively transferred T cells that are genetically modified using a self-inactivating (SIN) lentiviral vector to express a CD123-specific, CD28-costimulatory chimeric antigen receptor (CAR) as well as a truncated human epidermal growth factor receptor (EGFRt) (CD123.CD28.CD3ζ.EGFRt+T cells) derived from autologous leukapheresis which is administered after a lymphodepletion regimen.~Single dose of MB-102 up to 600 x 10 6 CART-T+ cells (Day 0) as defined by Phase 1 will be administered."

DRUG

Fludarabine

"Fludarabine 30 mg/m2/day IV (3 days) on days -5, -4, and -3~* A 20% dose reduction (24 mg/m2/day IV (3 days) on days -5, -4, and -3) is required for patients with moderately impaired renal function (creatine clearance ≤ 70 mL/min)."

DRUG

Cyclophosphamide

Cyclophosphamide 300 - 500 mg/m2/day IV (3 days) on days -5, -4, and -3

Trial Locations (4)

27710

Duke University, Durham

77030

MD Anderson Cancer Center, Houston

91010

City of Hope Medical Center, Duarte

02215

Dana-Farber Cancer Institute, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mustang Bio

INDUSTRY