Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07566585

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

Led by BlueSphere Bio, Inc · Updated on 2026-05-05

19

Participants Needed

1

Research Sites

71 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to test BSB-2002 which is a new type of cellular therapy to treat blood cancer (AML). It will evaluate the safety of BSB-2002 and also determine whether it works to prevent relapse of your cancer.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 18 years or older
  • Diagnosed with AML per ELN criteria and treated with at least two lines of therapy
  • AML is relapsed (after previous remission) or refractory to last treatment
  • MRD positive by NGS for NPM1 after previously being MRD negative
  • HLA-A*02:01 positive
  • Positive for NPM1 mutation type A, D, G, or H
  • Adequate venous access for apheresis or agree to central line use
  • Willing and able to provide informed consent and follow study requirements
Not Eligible

You will not qualify if you...

  • Leukemic blast count above 20,000/µl unless controlled with hydroxyurea
  • AML with only extramedullary involvement
  • Candidates for hematopoietic stem cell transplant
  • Eligible to receive approved targeted therapy
  • Use of other investigational agents within 5 half-lives before dosing
  • Hematopoietic stem cell transplant within 3 months or with significant graft-versus-host disease or persistent Grade 2+ toxicity
  • Other malignancies requiring treatment
  • Uncontrolled bacterial, viral, or fungal infections
  • Active Hepatitis B or C infection
  • HIV-1 or HIV-2 positive
  • CNS involvement refractory to treatment
  • Congestive heart failure NYHA class 3 or 4 or recent history without adequate heart function
  • Renal insufficiency with creatinine clearance below 40 ml/min/1.73m2 or serum creatinine above 1.6 mg/dL
  • Total bilirubin more than twice the upper limit of normal unless due to Gilbert's Syndrome
  • AST or ALT more than three times the upper limit of normal
  • Pregnant or lactating women
  • ECOG performance status greater than 2
  • Ongoing treatment with chronic immunosuppressants
  • Women of childbearing potential and fertile men unwilling to use effective birth control or abstinence for 12 months
  • Any condition that may interfere with participation or study data interpretation as judged by the Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Washington University at St Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

M

Medical Director: Nawazish Khan, BlueSphere Bio, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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