Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leu… (NCT07566585) | Clinical Trial Compass
RecruitingPhase 1
Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation
United States19 participantsStarted 2026-04-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Patients who are MRD positive by NGS for NPM1 after being MRD negative following the last treatment
✓. HLA-A\*02:01,
✓. Positive for NPM1 mutation type A, D, G or H (see Appendix 3)2
✓. Adequate venous access for apheresis or agree to use of a central line for apheresis collection,
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Number of participants with dose-limiting toxicity, adverse events (AEs) and serious AEs (SAEs)
Timeframe: 365 days
Trial details
NCT IDNCT07566585
SponsorBlueSphere Bio, Inc
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-08
Contact for this trial
Medical Director: Nawazish Khan, BlueSphere Bio, MD