The purpose of this clinical trial is to learn if the study treatment Loncastuximab tesirine and Rituximab is safe and efficient before standard of care chimeric antigen receptor T-cell (CAR-T) therapy in patients with relapsed or refractory large B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Patients will receive Loncastuximab Tesirine intravenously for 1-6 cycles (every 21 days) prior to standard of care CAR-T cell therapy.
Rituximab is administered intravenously for 1-6 cycles (every 21 days) prior to standard of care CAR-T cell therapy.
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
RECRUITINGThe complete response (CR) rate at D30 post CAR-T(+/- 7 days) post CAR-T administration per Lugano 2014 criteria.
To evaluate the efficacy of SOC CAR T-cell therapy in patients with R/R large B-cell lymphoma following bridging with lonca-R.
Time frame: 1 month
Duration of cytopenias post CAR-T (as defined by the NIH CTCAE, version 5.0) D30 post CAR-T (+/- 7 days).
To evaluate toxicities post CAR-T
Time frame: 1 month
Severity of cytopenias post CAR-T (as defined by the NIH CTCAE, version 5.0) D30 (+/- 7 days).
To evaluate toxicities post CAR-T
Time frame: 1 month
Rate of infections D30 (+/- 7 days).
To evaluate toxicities post CAR-T
Time frame: 1 month
CD19 expression as measured by flow cytometry and IHC on biopsies obtained pre- and post-lonca-R (optional) and post-CAR-T (optional but strongly recommended)
To determine whether CD19 expression is reduced in patients who receive bridging with lonca-R prior to CAR-T.
Time frame: 5 years
ORR defined as the proportion of subjects achieving a confirmed PR or CR at D30 (+/- 7 days) post CAR-T per Lugano 2014 criteria1.
To evaluate the level of disease control provided by bridging lonca-R
Time frame: 1 month
Best response rate per Lugano 2014 criteria following CAR-T (based on imaging up until D90 post CAR-T)
To evaluate the level of disease control provided by bridging lonca-R
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Time frame: 3 months
ORR defined as the proportion of subjects achieving a confirmed PR or CR post lonca-R (pre-CAR-T)
To evaluate the level of disease control provided by bridging lonca-R
Time frame: 5 years
Level of disease control (measured as percentage) with lonca-R as evaluated by CT measurements and metabolic tumor volume on PET pre and post Lonca-R
To evaluate the level of disease control provided by bridging lonca-R
Time frame: 5 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0)
To assess the safety and tolerability of lonca-R in the study population.
Time frame: 5 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
To assess the safety and tolerability of lonca-R in the study population.
Time frame: 5 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
To assess the safety and tolerability of lonca-R in the study population.
Time frame: 5 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.
To assess the safety and tolerability of lonca-R in the study population.
Time frame: 5 years