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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBlueSphere Bio, Inc

About this trial

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.

Eligibility criteria

Qualifiers

Male or female patients, ages 18 years or older,

AML diagnosed per ELN criteria1 which has been treated with at least two lines of therapy,

which is relapsed (after previously complete remission, CR, CRh or CRi), or

refractory (failed to achieve complete remission) to the last treatment*, *Primary refractory patients should have received at least two cycles of induction treatment

Disqualifiers

Leukemic blast count of >20,000/μl. If the blast count can be maintained below the threshold with hydroxyurea, the patient would be eligible.

Patients with extramedullary only AML.

Patients that are candidates for hematopoietic stem cell transplant.

Patients that are eligible to receive an approved targeted therapy.

Trial design

Treatments tested in this trial

  • SOC+ BSB-2002
  • SOC+BSB-2002

Treatment groups

19 Participants
are divided into 2 treatment groups

Sponsors and collaborators