A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia
M.D. Anderson Cancer Center
Summary
To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART.
Description
Primary Objectives: \- To evaluate the efficacy of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART. Secondary Objectives: \- To evaluate safety and tolerability of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART. Exploratory Objective: \- To investigate biomarkers of response and resistance to emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Eligible participants will be considered for inclusion in this study if they meet the following criteria based on tests obtained less than 4 weeks from first dose: 1. Relapsed or refractory FL (grade 1, 2, 3a and 3b), MCL, DLBCL, PMBCL, tFL, or HGBCL 2. Received standard of care therapy with axi-cel, tisa-cel or liso-cel 3. Age ≥ 18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 5. Either in remission after CART and/or with refractory/progressive disease not requiring urgent treatment in the opinion of the treating physician 6. Grade 3-…
Interventions
- DrugEmapalumab
Given by Infusion
Location
- MD Anderson Cancer CenterHouston, Texas