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NCT07566585 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by BlueSphere Bio.

Recruiting
Registry status
Phase 1
Development phase
19
Enrollment target

NCT07566585: Recruiting Phase 1 study, sponsored by BlueSphere Bio.

NCT07566585 is a Phase 1 study that is actively recruiting participants, run by BlueSphere Bio. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07566585, a Phase 1 study, is actively recruiting participants, sponsored by BlueSphere Bio.

RECRUITING
Registry status
Phase 1
Development phase
19 participants
Enrollment target

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.

Primary Outcome

Incidence of dose-limiting toxicity, frequency and severity of adverse events (AEs) and serious AEs (SAEs)

Interventions

  • DRUG SOC+ BSB-2002
  • DRUG SOC+BSB-2002

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2026-04-21
Est. Completion 2027-09
Phase Phase 1
BlueSphere Bio

2 total trials

What NCT07566585 shows while recruiting

NCT07566585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 2 interventions - of which SOC+ BSB-2002 is the first listed.

NCT07566585 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07566585 about?

NCT07566585 is a clinical study titled "Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation". 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.

What is the current status of trial NCT07566585?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2026-04-21. Estimated completion is 2027-09.

What interventions are being tested in trial NCT07566585?

The interventions under investigation include: SOC+ BSB-2002 (DRUG), SOC+BSB-2002 (DRUG).

Who is sponsoring clinical trial NCT07566585?

This trial is sponsored by BlueSphere Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07566585's enrollment target sits among peer trials

19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07566585, the US trial registry maintained by the National Library of Medicine. NCT07566585 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.