A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies

Stopped early · Phase 1

Conditions studied: R/R CD19-Positive B-Cell Malignancies, Indolent Non-Hodgkin Lymphoma, Aggressive Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT05336409

Run by

Century Therapeutics, Inc.

People needed

28

Starts

2023-01-24

Expected to finish

2025-07-01

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• University of Southern California - Norris Comprehensive Cancer Center — Los Angeles, California, United States
• 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
• Oncology Hematology Care, Inc-Kenwood — Cincinnati, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• UT Southwestern — Dallas, Texas, United States
• Houston Methodist Research Institute — Houston, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Swedish Cancer Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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