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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

NCT07566585 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

SOC+ BSB-2002

Patients will receive BSB-2002 as a single IV infusion at day 1 following the lymphodepletion regime.

DRUG

SOC+BSB-2002

Patients will receive BSB-2002 as a single IV infusion at day 1 following the lymphodepletion regime.

Sponsors & Collaborators

  • BlueSphere Bio, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-21
Primary Completion
2027-08-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566585 on ClinicalTrials.gov