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NCT07583303 · ClinicalTrials.gov registry record · Phase 1
BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation
A Phase 1 study, sponsored by City of Hope Medical Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT07583303 is a Phase 1 study that has not yet begun recruiting, run by City of Hope Medical Center. The registered enrollment target is 19 participants.
The verdict
NCT07583303, a Phase 1 study, has not yet begun recruiting, sponsored by City of Hope Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of BSB-2002 when given after cyclophosphamide and fludarabine and tests how well it works in treating NPM1-mutated acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BSB-2002 is a type of personalized autologous T cell receptor-modified T cell therapy. T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study come from the patient and have a new gene put in them that makes them able to recognize mutated NPM1, a protein on the surface of cancer cells. These NPM1 mutated-specific T cells may help the body's immune system identify and kill NPM1-mutated AML cells. Giving chemotherapy, such as cyclophosphamide and fludarabine, before BSB-2002 helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Giving BSB-2002 after cyclophosphamide and fludarabine may be safe, tolerable, and/or effective in treating relapsed or refractory AML in patients with NPM1 mutation.
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Echocardiography Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2026-12-14 |
| Est. Completion | 2027-04-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07583303
The ClinicalTrials.gov registry entry for NCT07583303 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT07583303 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07583303 about?
NCT07583303 is a clinical study titled "BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation". This phase I trial studies the side effects and best dose of BSB-2002 when given after cyclophosphamide and fludarabine and tests how well it works in treating NPM1-mutated acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that does not respond to treatment ...
What is the current status of trial NCT07583303?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2026-12-14. Estimated completion is 2027-04-16.
What interventions are being tested in trial NCT07583303?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Echocardiography Test (PROCEDURE).
Who is sponsoring clinical trial NCT07583303?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
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