BSB-2002 for Relapsed or Refractory AML with NPM1 Mutation

This study is testing a new cell therapy called BSB-2002 for people with acute myeloid leukemia (AML), a type of blood cancer. Specifically, it's for AML that has come back (relapsed) or hasn't responded to at least two previous treatments (refractory), and has a specific gene change called an NPM1 mutation. The main goal is to see how safe BSB-2002 is and to find the right dose. It will also look at whether BSB-2002 can help prevent your cancer from returning. You would receive BSB-2002 as a single infusion after a preparation treatment. This study is currently recruiting about 19 adult patients.

Study design
This is a Phase 1, open-label study without randomization, meaning all participants will receive BSB-2002. It will involve up to 3 groups of participants to find the safest dose.
What's involved
You would receive BSB-2002 as a single intravenous (IV) infusion on day 1, after a preparation treatment. The study will monitor your safety for 365 days.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for 365 days after receiving the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07566585

Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation

Recruiting
PHASE1Ages 18+InterventionalTreatment
BlueSphere Bio, Inc
~19 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:SOC+ BSB-2002SOC+BSB-2002

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with dose-limiting toxicity, adverse events (AEs) and serious AEs (SAEs)
Measured over 365 days
AML - Acute Myeloid Leukemia
AML With Mutated NPM1
AML, Adult Recurrent
1 sites across 1 states
Missouri1
Medical Director: Nawazish Khan, BlueSphere Bio, MD
Email the study team

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  • Number of participants with dose-limiting toxicity, adverse events (AEs) and serious AEs (SAEs)365 days

    Incidence of dose-limiting toxicity, frequency and severity of adverse events (AEs) and serious AEs (SAEs)