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Tests treatment safety and results for AML - Acute Myeloid Leukemia
Official title Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation
ClinicalTrials.gov ID: NCT07566585
What this study is testing
What is SOC+ BSB-2002?
SOC+ BSB-2002 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aml - acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients, ages 18 years or older,
- AML diagnosed per ELN criteria1 which has been treated with at least two lines of therapy,
- which is relapsed (after previously complete remission, CR, CRh or CRi), or
- refractory (failed to achieve complete remission) to the last treatment\ , \ Primary refractory patients should have received at least two cycles of...
- Patients who are MRD positive by NGS for NPM1 after being MRD negative following the last treatment
You likely can't join if
- Leukemic blast count of \>20,000/μl. If the blast count can be maintained below the threshold with hydroxyurea, the patient would be eligible.
- Patients with extramedullary only AML.
- Patients that are candidates for hematopoietic stem cell transplant.
- Patients that are eligible to receive an approved targeted therapy.
- Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-2002 (day 1).
- Subject has had hematopoietic stem cell transplant (HSCT) and has any of the following:
See the full eligibility criteria
- Male or female patients, ages 18 years or older,
- AML diagnosed per ELN criteria1 which has been treated with at least two lines of therapy,
- which is relapsed (after previously complete remission, CR, CRh or CRi), or
- refractory (failed to achieve complete remission) to the last treatment\ , \ Primary refractory patients should have received at least two cycles of induction treatment
- Patients who are MRD positive by NGS for NPM1 after being MRD negative following the last treatment
- HLA-A\ 02:01,
- Positive for NPM1 mutation type A, D, G or H (see Appendix 3)2
- Adequate venous access for apheresis or agree to use of a central line for apheresis collection,
- Willing and able to provide informed consent and adhere to all study requirements.
- Leukemic blast count of \>20,000/μl. If the blast count can be maintained below the threshold with hydroxyurea, the patient would be eligible.
- Patients with extramedullary only AML.
- Patients that are candidates for hematopoietic stem cell transplant.
- Patients that are eligible to receive an approved targeted therapy.
- Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-2002 (day 1).
- Subject has had hematopoietic stem cell transplant (HSCT) and has any of the following:
- Is within 3 months of transplant;
- Has clinically significant graft-versus-host disease requiring systemic treatment;
- Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant.
- Other malignancy that requires treatment.
- Uncontrolled bacterial, viral, or fungal infections at time of enrollment.
- Active Hepatitis B or C infection.
- Seropositive for Human Immunodeficiency Virus-1 or -2.
- CNS involvement refractory to intrathecal chemotherapy and/or standard cranial- spinal radiation.
- Subject has congestive heart failure NYHA class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless an echocardiogram performed within 3 months prior to study entry...
- Renal insufficiency, with estimated creatinine clearance of \ 1.6 mg/dL
- Total bilirubin \> 2x upper limit of normal (unless attributed to Gilbert's Syndrome).
- AST or ALT \> 3x upper limit of normal.
- Pregnant or lactating women.
- Eastern Cooperative Oncology Group (ECOG) performance status \>2.
- Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids at any dose)
- Women of childbearing potential (WOCBP) and men who are fertile and are unwilling to use an effective birth control method or abstinence for 12 months. Effective forms of birth control are listed in the Contraception...
- Any condition, in the judgement of the Investigator, that would interfere with study participation, pose a significant risk to the patient, or interfere with study data interpretation.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.