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.
Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- 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)