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Alkylating agents

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

Phase 1 & 2
Waitlist Available
Led By Lihua E Budde, MD
Research Sponsored by Mustang Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment called MB-102 for patients with BPDCN, a type of cancer that has come back or did not respond to other treatments. The study will determine the safest dose and evaluate the effectiveness of MB-102 for these patients.

Eligible Conditions
  • Blastic Plasmacytoid Dendritic Cell Neoplasm

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Maximum Tolerated Dose (MTD) and recommended Phase 2 dose
Phase 1: Safety and Tolerability as measured by the number of patients with treatment related adverse events
Phase 2: Response Rate of patients with BPDCN
Secondary study objectives
Phase 2 - Adverse events
Phase 2 - Change from Baseline in the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Version 4.0.
Phase 2 - Number of patients showing evidence of replication competent lentivirus
+5 more

Side effects data

From 2023 Phase 3 trial • 249 Patients • NCT05425719
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
eGFR ≥ 70 mL/Min/1.73 m^2
eGFR < 70 mL/Min/1.73 m^2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Relapsed or Refractory BPDCNExperimental Treatment3 Interventions
Treatment with MB-102.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860
MB-102
2023
Completed Phase 3
~420

Find a Location

Who is running the clinical trial?

Mustang BioLead Sponsor
3 Previous Clinical Trials
76 Total Patients Enrolled
Lihua E Budde, MDPrincipal InvestigatorCity of Hope Medical Center
~1 spots leftby Dec 2025
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