A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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.
EXCLUSION CRITERIA
Exclusion Criteria:
- 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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
R/R CD19-Positive B-Cell Malignancies,Indolent Non-Hodgkin Lymphoma,Aggressive Non-Hodgkin Lymphoma
Age
18+
Phase
PHASE1
Participants Needed
75
Est. Completion Date
Aug 31, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Century Therapeutics, Inc.
ClinicalTrials.gov NCT Identifier
NCT05336409
Study Number
CNTY-101-111-01
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