BSB-2002 + Chemotherapy for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose and assess the side effects of a new treatment called BSB-2002 for acute myeloid leukemia (AML) that has returned or not responded to treatment. BSB-2002 is a personalized T cell therapy that modifies the patient's own T cells to better recognize and attack cancer cells with a specific NPM1 mutation. Participants first receive chemotherapy to prepare the body, followed by the BSB-2002 infusion. The trial seeks individuals diagnosed with AML, possessing the NPM1 mutation, and who have not responded to at least two previous treatments. As a Phase 1 trial, this research focuses on understanding how BSB-2002 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial requires that certain medications be stopped before participating. Specifically, systemic chemotherapy must be stopped at least 2 weeks or 5 half-lives before leukapheresis, and hydroxyurea must be stopped before lymphodepletion. Some medications like steroids and vincristine have specific timeframes for discontinuation.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that BSB-2002, a new type of cell therapy, is under testing for safety and effectiveness in treating relapsed or refractory acute myeloid leukemia (AML). In earlier studies, researchers administered BSB-2002 after chemotherapy drugs cyclophosphamide and fludarabine. These studies suggest that BSB-2002 might be safe and manageable for patients.
However, since this treatment remains in the early testing stages, detailed safety information is limited. Early-phase trials primarily focus on identifying the safest dose and understanding possible side effects. While initial results appear promising, more research is necessary to confirm safety in larger groups. Researchers closely monitor participants for any side effects or unexpected reactions.12345Why do researchers think this study treatment might be promising for AML?
Unlike the standard chemotherapy treatments for acute myeloid leukemia, which often include drugs like cytarabine and daunorubicin, BSB-2002 offers a novel approach by leveraging personalized cell therapy. Researchers are excited about BSB-2002 because it involves engineering a patient's own cells to specifically target and attack leukemia cells, potentially leading to more precise and effective treatment. This method could result in fewer side effects compared to traditional chemotherapy, which generally impacts both healthy and cancerous cells. Additionally, the use of BSB-2002 may provide an option for patients who haven't responded well to existing therapies.
What evidence suggests that BSB-2002 combined with chemotherapy could be effective for NPM1-mutated acute myeloid leukemia?
Research has shown that BSB-2002 is a promising treatment for acute myeloid leukemia (AML) that is recurrent or difficult to treat, particularly with NPM1 mutations. This therapy personalizes treatment by modifying a patient's own T cells, part of the immune system, to target and attack cancer cells. In this trial, participants will receive BSB-2002 after chemotherapy with cyclophosphamide and fludarabine. Early studies suggest this combination might effectively target these cancer cells. Although detailed human data remains limited, the treatment shows promise by specifically attacking the mutated proteins in AML. Initial results are encouraging, but further research is needed to confirm its efficacy.13678
Who Is on the Research Team?
Ryotaro Nakamura
Principal Investigator
City of Hope Medical Center
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 to treatment, and who have a specific NPM1 gene mutation. Participants must be in good physical condition, able to undergo blood collection procedures, and at least 3 months out from any stem cell transplant.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis
Patients undergo leukapheresis for manufacturing of BSB-2002
Chemotherapy
Patients receive cyclophosphamide and fludarabine intravenously
Treatment
BSB-2002 administered intravenously over 30 minutes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BSB-2002
- Cyclophosphamide
- Fludarabine
Trial Overview
The study tests BSB-2002, a personalized T cell therapy made from the patient's own cells modified to target cancer cells with an NPM1 mutation. Before receiving BSB-2002, patients get chemotherapy drugs cyclophosphamide and fludarabine to prepare their body.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo leukapheresis between days -45 and -21 for manufacturing of BSB-2002. Patients then receive cyclophosphamide IV and fludarabine IV on days -5 to -3 followed by BSB-2002 IV over 30 minutes on day 0 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection as well as bone marrow aspiration and possible biopsy throughout the study. Patients also undergo echocardiography during screening.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
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 ...
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 + Chemotherapy for Acute Myeloid Leukemia
Giving BSB-2002 after cyclophosphamide and fludarabine may be safe, tolerable, and/or effective in treating relapsed or refractory AML in patients with NPM1 ...
The outcomes and costs of acute myeloid leukemia among ...
Conclusions: Among the elderly, AML is associated with a poor prognosis and substantial costs during the relatively few remaining months of life. Moreover, most ...
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).
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ctv.veeva.com
ctv.veeva.com/study/bsb-2002-after-cyclophosphamide-and-fludarabine-for-the-treatment-of-relapsed-or-refractory-acute-myBSB-2002 After Cyclophosphamide and Fludarabine for the ...
Giving BSB-2002 after cyclophosphamide and fludarabine may be safe, tolerable, and/or effective in treating relapsed or refractory AML in ...
Results of the AIEOP AML 2002/01 multicenter prospective ...
We evaluated the outcome of 482 children with acute myeloid leukemia (AML) enrolled in the Associazione Italiana di Ematologia e Oncologia ...
BSB-2002 After Cyclophosphamide and Fludarabine ...
Tables will include system organ class, high-level term, and severity grade. Listings will also include treatment interruption or discontinuation, dose level, ...
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