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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
BlueSphere Bio, Inc
Study ID
NCT07566585
Phase
PHASE1
Status
Recruiting
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Conditions

  • AML - Acute Myeloid Leukemia
  • AML With Mutated NPM1
  • AML, Adult Recurrent

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SOC+ BSB-2002 — DRUG
    Patients will receive BSB-2002 as a single IV infusion at day 1 following the lymphodepletion regime.
  • SOC+BSB-2002 — DRUG
    Patients will receive BSB-2002 as a single IV infusion at day 1 following the lymphodepletion regime.

Study Details

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.

Key Dates

Start date
Apr 21, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
19 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohorts
    AML HLA-A\*02:01 and Positive for NPM1 mutation type A, D, G or H patients with an identified will be dosed in dose escalation cohorts
  • Experimental: Expansion Cohort
    Once the maximum tolerated dose (MTD) or promising dose is reached additional AML HLA-A\*02:01 and Positive for NPM1 mutation type A, D, G or H patients will be enrolled in the expansion cohort.

Primary Outcome Measure

Number of participants with dose-limiting toxicity, adverse events (AEs) and serious AEs (SAEs) [ Time Frame: 365 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University at St LouisSt LouisMissouri63110-

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By research site
Washington University at St Louis· St Louis, MO

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