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

NCT04109482 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-07-22

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

  • Mustang Bio

    lead INDUSTRY

Principal Investigators

  • Lihua E Budde, MD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-17
Primary Completion
2023-05-17
Completion
2023-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04109482 on ClinicalTrials.gov