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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?

This trial explores a new treatment called BSB-2002 for acute myeloid leukemia (AML), a type of blood cancer. The main goal is to determine if BSB-2002 is safe and effective in preventing cancer recurrence. The trial consists of two parts, where patients receive different doses to identify the optimal one. Suitable candidates for this trial have AML that hasn't responded well to other treatments and possess specific genetic markers, such as HLA-A*02:01 and NPM1 mutation types A, D, G, or H. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on chronic immunosuppressants or have taken other investigational agents recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that BSB-2002 is likely to be safe for humans?

Research has shown that BSB-2002 is undergoing safety testing for treating acute myeloid leukemia (AML), a type of blood cancer. Early results suggest that BSB-2002, when combined with treatments like cyclophosphamide and fludarabine, might be safe and manageable for patients whose AML has returned or hasn't responded to other treatments. These studies aim to determine the optimal dose with the fewest side effects.

Researchers closely monitor patient responses to the treatment, ensuring that any side effects remain manageable. As BSB-2002 is in the early testing phase, researchers continue to gather information about its safety. This phase is crucial for understanding patient tolerance and identifying any potential side effects.

Overall, BSB-2002 remains under study, so safety information is limited. However, these studies are vital for understanding patient reactions and ensuring the treatment's safety.12345

Why do researchers think this study treatment might be promising for AML?

BSB-2002 is unique because it specifically targets acute myeloid leukemia (AML) patients with certain genetic markers, namely the HLA-A*02:01 type and NPM1 mutation types A, D, G, or H. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, BSB-2002 is designed to precisely home in on these genetic targets, potentially reducing collateral damage to healthy cells. This precision targeting could lead to fewer side effects and more effective treatment outcomes, making researchers hopeful for its potential to improve patient quality of life compared to current therapies.

What evidence suggests that BSB-2002 might be an effective treatment for AML?

Research has shown that BSB-2002 is a promising new treatment for acute myeloid leukemia (AML), a type of blood cancer. Early studies suggest it could be safe and effective. In this trial, participants will join either dose escalation cohorts or an expansion cohort to determine the optimal dosing. The goal is to prevent cancer recurrence by targeting specific cells. While detailed results from human studies are still emerging, this treatment aims to enhance the immune system's ability to fight cancer cells. Although still under study, the initial findings offer hope for people with AML.12346

Are You a Good Fit for This Trial?

This trial is for adults (18+) with acute myeloid leukemia (AML) that has come back or not responded after at least two treatments, who have a specific NPM1 gene mutation and are HLA-A*02:01 positive. Participants must be able to undergo blood cell collection and agree to all study requirements.

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

Trial Overview

The study is testing the safety of BSB-2002, a new cellular therapy, given along with standard care in people with relapsed or refractory AML. The main goal is to find the best dose and see if it helps prevent cancer from coming back.

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+

Citations

Dose Finding Study to Evaluate the Safety of BSB-2002 in ...

The goal of this clinical trial is to test BSB-2002 which is a new type of cellular therapy to treat blood cancer (AML).

Dose Finding Study to Evaluate the Safety of BSB-2002 in ...

The goal of this clinical trial is to test BSB-2002 which is a new type of cellular therapy to treat blood cancer (AML).

BSB-2002 After Cyclophosphamide and Fludarabine for ...

Giving BSB-2002 after cyclophosphamide and fludarabine may be safe, tolerable, and/or effective in treating relapsed or refractory AML in ...

BSB-2002 for Acute Myeloid Leukemia

This Phase 1 medical study run by BlueSphere Bio, Inc is evaluating whether BSB-2002 will have tolerable side effects & efficacy for patients with Acute ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/23673857/

Results of the AIEOP AML 2002/01 multicenter prospective ...

The 8-year overall survival (OS), event-free survival (EFS), and disease-free survival (DFS) were 68%, 55%, and 63%, respectively. OS ...

Dose Finding Study to Evaluate the Safety of BSB-2002 in ...

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 ...