NCT04109482

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

A Phase 1/2, Open Label, Multicenter Trial to Assess the Safety and Efficacy of MB-102 in Patients With Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Mustang Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 1/2 study to assess the safety and efficacy of MB-102 in patients with relapsed or refractory BPDCN

Detailed description

The Phase 1 portion of the study will determine the maximum tolerated dose of MB-102. The Phase 2 portion of the trial will evaluate the efficacy of MB-102 in relapsed or refractory BPDCN.

Conditions

• Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-02-17
• Primary completion: 2023-05-17
• Completion: 2023-05-17
• First posted: 2019-09-30
• Last updated: 2024-07-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study