This is a Phase 1b/2, multicenter, open-label, study of prizloncabtagene autoleucel (prizlo-cel), an autologous dual targeting chimeric antigen receptor (CAR) T-cell therapy targeting both cluster of differentiation (CD) CD20 and CD19, for the treatment of adult participants with relapsed or refractory (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or frontline high-risk diffuse large B-cell lymphoma (DLBCL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
439
Prizlo-Cel, an autologous dual targeting chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)20 and CD19.
City of Hope
Duarte, California, United States
RECRUITINGColorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
SUSPENDEDUniversity of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability]
Occurrence of any AEs, including dose limiting toxicities (DLTs).
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 2: Overall Response (OR) As Assessed by Independent Review Committee (IRC)
Overall response is defined as a PR or CR at any point between the time of prizlo-cel infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first (per Lugano 2014 guidelines).
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 1b: Overall Response (OR)
Overall response is defined as a PR or CR at any point between the time of prizlo-cel infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first (per Lugano 2014 guidelines).
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 1b: Duration of Response (DOR)
DOR is defined as the time from the first documented CR or PR after prizlo-cel infusion until PD or death, whichever occurs first (per Lugano 2014 guidelines).
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 1b: Pharmacokinetic Evaluation of Prizlo-Cel
Prizlo-cel blood levels will be reported.
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 2: Occurrence of Adverse Events (AEs) by Severity
Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening ), Grade 5 (Death). Cytokine release syndrome (CRS), Immune effector cell-associated neurotoxicity syndrome (ICANS), and Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 2: Complete Response (CR)
A CR is defined as at any point between the date of prizlo-cel infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first.
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 2: Duration of Response (DOR)
DOR is defined as the time from the first documented CR or PR after prizlo-cel infusion to relapse or death, whichever occurs first.
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 2: Progression Free Survival (PFS)
PFS is defined as the time from the date of prizlo-cel infusion to the date of first documented disease progression, or death due to any cause, whichever occurs first.
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of prizlo-cel infusion to the date of death due to any cause.
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 2: Maximum Observed Blood Concentration (Cmax) for Prizlo-Cel
Blood samples will be analyzed to report Cmax for prizlo-cel.
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 2: Time to Reach Maximum Observed Cmax (Tmax) for Prizlo-Cel
Blood samples will be analyzed to report Tmax for prizlo-cel.
Time frame: Up to 2 Years post prizlo-cel infusion
Phase 2: Area Under the Blood Concentration Time Curve (AUC) for Prizlo-Cel
AUC for prizlo-cel will be reported.
Time frame: Up to 2 Years post prizlo-cel infusion
Change From Baseline of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Symptom Score
The FACT-Lym was developed for adult patients with lymphoma. The FACT Lym is self-administered, with a recall period for all items being the past 7 days. Responses are rated on a 5-point Likert response scale ranging from 0 "not at all" to 4 "very much". Higher scores indicate fewer symptoms and better well-being.
Time frame: From Baseline Up to 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Kentucky Medical Center
Lexington, Kentucky, United States
RECRUITINGRutgers Cancer Institute of New Jersey
Piscataway, New Jersey, United States
RECRUITINGLevine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RECRUITINGGreco Hainesworth Tennessee Oncology Centers for Research
Nashville, Tennessee, United States
RECRUITING...and 23 more locations