A Phase Ib, Open Label Study to Evaluate Safety of Axicabtagene Ciloleucel Reinfusion (Axi-Cel-2) in Patients With Relapsed and/or Refractory Second Line High-Risk Non-Hodgkin Lymphoma After Standard of Care Axi-Cel
Stanford University
Summary
This is a phase Ib study to establish safety of Axi-Cel-2 in patients with Large B Cell Lymphoma (LBCL) who are at high risk of relapse.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis: Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2008: * Diffuse large B cell lymphoma (DLBCL); OR * primary mediastinal (thymic) large B cell lymphoma; OR * transformation of follicular lymphoma (TFL), marginal zone lymphoma to DLBCL; OR * high grade B-cell Lymphoma NOS will also be included 2. Patients must be considered high-risk lymphoma (defined as LDH greater than upper limit of normal per institutional cut-off) at or within two weeks of leukapheresis. 3. Subjects must have received at least and a…
Interventions
- DrugAxicabtagene Ciloleucel
Subjects will receive a re-infusion of Axi-Cel (Axi-Cel-2) if signs and symptoms of cytokine release syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS) are ≤ grade 1.
Location
- Stanford UniversityPalo Alto, California