ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety, pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or refractory cluster of differentiation (CD)19-positive B-cell malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity
Time frame: Up to 28 days
Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)
Time frame: Up to 28 days
Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR)
CRR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
Time frame: Up to 2 years
Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR)
ORR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
Time frame: Up to 2 years
Duration of Response (DOR)
DOR is defined as time from first response (CR or PR) to the first documentation of progressive disease (PD) or death.
Time frame: Up to 2 years
Time to Treatment Response (TTR)
TTR is defined as time from first CNTY-101 infusion to the first documentation of response (CR or PR).
Time frame: Day 1 up to 2 years
Progression-Free Survival (PFS)
PFS is defined as time from first CNTY-101 infusion to the first documentation of PD, or death from any cause, whichever occurs first
Time frame: Day 1 up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California San Diego, Moores Cancer Center
San Diego, California, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
...and 6 more locations
Overall Survival (OS)
OS is defined as time from CNTY-101 infusion to death.
Time frame: Day 1 up to 2 years
Cmax: Maximum Observed Plasma Concentration for CNTY-101
Time frame: Day 1 up to 2 years
Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101
Time frame: Day 1 up to 2 years
t1/2: Terminal Disposition Phase Half-life for CNTY-101
Time frame: Day 1 up to 2 years
AUC: Area under the Concentration-time Curve for CNTY-101
Time frame: Day 1 up to 2 years
Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)
Time frame: Day 1 up to 2 years
Percentage of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Day 1 up to 2 years
Time to Treatment Initiation
Time to treatment initiation is defined as the time from enrollment in the study to first CNTY-101 infusion.
Time frame: Enrollment to first CNTY-101 infusion (up to approximately 2 weeks)