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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


Description

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 Eligibility

Inclusion Criteria: 1. Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL). 2. Must have met the following criteria for prior treatment: 1. 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. 2. 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. 3. Participants with marginal zone lymphoma (MZL) must have received at least 2 prior systemic therapies. 3. Measurable disease on screening evaluations. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Adequate organ function. 6. Life expectancy of ≥12 weeks. Exclusion Criteria: 1. Any condition that confounds the ability to interpret data from the study. 2. Central nervous system (CNS)-only involvement by malignancy. (Note: participants with secondary CNS involvement are allowed.) 3. Prior allogeneic stem cell transplant. 4. Presence of clinically significant CNS pathology. 5. Other comorbid conditions defined in the protocol. 6. Use of prohibited medications within the washout period defined in the protocol.

Study Info

Organization

Century Therapeutics, Inc.


Primary Outcome

Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity


Outcome Timeframe Up to 28 days

NCTID NCT05336409

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2023-01-24

Completion Date 2025-08

Enrollment Target 75

Interventions

BIOLOGICAL CNTY-101

BIOLOGICAL IL-2

DRUG Lymphodepleting Chemotherapy

Locations Recruiting

Banner MD Anderson Cancer Center

United States, Arizona, Gilbert


University of Southern California - Norris Comprehensive Cancer Center

United States, California, Los Angeles


University of California San Diego, Moores Cancer Center

United States, California, San Diego


Medstar Georgetown University Hospital

United States, District of Columbia, Washington


University of Kentucky - Markey Cancer Center

United States, Kentucky, Lexington


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