Retreatment With CTL019/CTL119 in Patients With Late Relapse of B-Cell Lymphomas
University of Pennsylvania
Summary
This research study is designed to evaluate the effects of retreatment with CTL019/CTL119 in patients with late relapse of B-cell lymphomas.
Description
This is a single arm open label trial that will assess the safety and efficacy of retreatment with CTL019/CTL119 chimeric antigen receptor (CAR) modified T cells in patients who have late relapse of diffuse large B-cell or follicular lymphoma after achieving complete remission from prior CTL019/CTL119 treatment. Patients eligible for this protocol will have been treated initially with CTL019/CTL119 under UPCC13413/NCT02030834, have experienced a durable complete response (defined as ≥ 6 months duration), and have a residual manufactured CTL019/CTL119 product available. This protocol will serve…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+ 2. Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion 3. Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days) 4. No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to \< 2 year survival) with currently available therapies. 5. Age ≥18 years 6. Creatinine \< 1.6 mg/dL 7. ALT/AST \< 3x upper limit of no…
Interventions
- DrugCD19 redirected autologous T cells (CTL019 or CTL119 cells)
Retreatment with CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19 cells) or huCD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19 cells) in subjects with late relapse of B-cell lymphomas.
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania