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NCT07758673

Genetically Engineered Cells (BAFFR-CAR T Cells) for the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Lymphoblastic Lymphoma

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 4 more changesShow less
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Study description revised
    • Site details revised at 2 of 2 sites
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence of adverse events
Timeframe: Up to 28 days after chimeric antigen receptor (CAR) T cells
Dose-limiting toxicity
Timeframe: From the start of CAR T infusion up to 28 days

Secondary (6)

Disease response rate
Minimal residual disease negative rate
Duration of B-cell aplasia
Severity of GVHD in recipients of prior allogeneic hematopoietic stem cell transplantation
Progression-free survival
Show 1 moreShow less
Overall survival

Arms and interventions

Treatment (BAFFR-CAR T cells)Experimental

Patients undergo leukapheresis and may receive bridging therapy per treating physician discretion. Patients then receive lymphodepletion therapy with cyclophosphamide IV and fludarabine IV on days -5 to -3 and BAFFR-CAR T cells IV over 10-15 minutes on day 0. Patients also undergo blood sample collection, bone marrow aspiration and biopsy, chest x-ray, and PET/CT or CT throughout the study. Additionally, patients may also undergo liver ultrasonographic elastography at screening at discretion of investigator and brain MRI or CT, CSF specimen collection, and ECHO or MUGA throughout the study.

Biologicals: Autologous BAFFR-targeting CAR T Cells

Procedures: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Bridge Therapy, Chest Radiography, Computed Tomography, Echocardiography Test, Leukapheresis, Magnetic Resonance Imaging, Multigated Acquisition Scan, Positron Emission Tomography, Ultrasonographic Elastography

Drugs: Cyclophosphamide, Fludarabine

Sites

2 sites in 1 country