Study Stopped
Strategic decision
A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
ELiPSE-1
The ELiPSE-1 Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects With Relapsed or Refractory CD19-Positive B-Cell Malignancies
1 other identifier
interventional
28
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2023
Typical duration for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedStudy Start
First participant enrolled
January 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedDecember 18, 2025
December 1, 2025
2.4 years
April 8, 2022
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity
Up to 28 days
Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)
Up to 28 days
Secondary Outcomes (13)
Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR)
Up to 2 years
Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR)
Up to 2 years
Duration of Response (DOR)
Up to 2 years
Time to Treatment Response (TTR)
Day 1 up to 2 years
Progression-Free Survival (PFS)
Day 1 up to 2 years
- +8 more secondary outcomes
Study Arms (2)
Dose Escalation: Schedule A
EXPERIMENTALLymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
Dose Escalation: Schedule B
EXPERIMENTALLDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
Interventions
CNTY-101 cells for intravenous (IV) infusion
IL-2 subcutaneous (SQ) injection
LDC as prespecified in the protocol.
Eligibility Criteria
You may qualify if:
- Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).
- Must have met the following criteria for prior treatment:
- Participants with aggressive NHL must have received at least 2 lines of systemic therapy (if not intended for transplant, have already undergone or be unwilling or unable to undergo chimeric antigen receptor \[CAR\] T-cell therapy to be eligible), or at least 3 lines of systemic therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylator.
- Participants with follicular lymphoma (FL) must have received at least 2 lines of systemic therapy and have high-risk disease. Previous therapy must have included a CD20-targeted agent and an alkylator.
- Participants with marginal zone lymphoma (MZL) must have received at least 2 prior systemic therapies.
- Measurable disease on screening evaluations.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
- Life expectancy of ≥12 weeks.
You may not qualify if:
- Any condition that confounds the ability to interpret data from the study.
- Central nervous system (CNS)-only involvement by malignancy. (Note: participants with secondary CNS involvement are allowed.)
- Prior allogeneic stem cell transplant.
- Presence of clinically significant CNS pathology.
- Other comorbid conditions defined in the protocol.
- Use of prohibited medications within the washout period defined in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California San Diego, Moores Cancer Center
San Diego, California, 92093, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, 40536, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229, United States
Oncology Hematology Care, Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
UT Southwestern
Dallas, Texas, 75390, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2022
First Posted
April 20, 2022
Study Start
January 24, 2023
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share