A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy
M.D. Anderson Cancer Center
Summary
To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.
Description
Primary Objective: -To evaluate the efficacy of lonca as consolidation therapy in patients with relapsed or refractory LBCL who achieve PR after CAR T-cell therapy. Secondary Objectives: -To evaluate safety and tolerability of lonca as consolidation therapy in patients with relapsed or refractory LBCL who achieve PR after CAR T-cell therapy. Exploratory Objective: -To determine the pharmacodynamic effects and investigate biomarkers of response and resistance of this novel consolidation therapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Eligible subjects will be considered for inclusion in this study if they meet the following criteria: 1. Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas and high-grade B-cell lymphoma 2. Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial 3. ≥ 18 years of age 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 5. Achievement of PR according to Lugano 2014 response criteria 30 days after CAR T-cel…
Interventions
- DrugLoncastuximab Tesirine
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas