Status:
TERMINATED
A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
Lead Sponsor:
Century Therapeutics, Inc.
Conditions:
R/R CD19-Positive B-Cell Malignancies
Indolent Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 differenti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05336409
Start Date
January 24 2023
End Date
July 1 2025
Last Update
December 18 2025
Active Locations (16)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
University of California San Diego, Moores Cancer Center
San Diego, California, United States, 92093
4
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007