19 Participants NeededMy employer runs this trial

BSB-2002 for Acute Myeloid Leukemia

MD
Overseen ByMedical Director: Nawazish Khan, BlueSphere Bio, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have AML diagnosed by ELN and have had at least two treatments for it.
My cancer has come back or did not respond after at least two treatments.
I have good veins for blood collection or agree to use a central line for it.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive single doses of BSB-2002 in dose escalation cohorts to evaluate safety and determine the maximum tolerated dose

12 weeks
Weekly visits for dose administration and monitoring

Expansion Cohort

Additional participants are enrolled to further evaluate the safety and efficacy at the maximum tolerated dose

12 weeks
Bi-weekly visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

365 days
Monthly visits for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

  • BSB-2002

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Expansion CohortExperimental Treatment1 Intervention
Group II: Dose Escalation CohortsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BlueSphere Bio, Inc

Lead Sponsor

Trials
1
Recruited
40+