Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Lymphomas
Stanford University
Summary
This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed / refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Disease: Must have histologically confirmed disease as defined by WHO 2016\[117\] of one of the following: Follicular Lymphoma, grade 1-3a 1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy (single-agent anti- CD20 antibody does not count as line of therapy for eligibility nor does local radiation). Anti-CD20 antibody is not required for participants with CD20 negative disease. A systemic therapy includes, but is not limited to: Bendamustine, CHOP…
Interventions
- DrugCD22CART Infusion
Dosing and Administration Participants will be hospitalized to receive treatment with CD22CART, if not previously hospitalized, and will remain hospitalized for approximately 5 to 7 (±2) days. Patients may be discharged once all AEs have resolved to Grade 1 or better, or at the discretion of the treating physician. Participants may be discharged with non critical and clinically stable or slowly improving toxicities (e.g., renal insufficiency, cytopenias) even if \> Grade 1, if deemed appropriate by the investigator.
Location
- Stanford UniversityPalo Alto, California