For Healthcare Professionals

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

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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.
  4. Measurable disease on screening evaluations.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Adequate organ function.
  7. Life expectancy of ≥12 weeks.

EXCLUSION CRITERIA

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.

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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.
Phone iconCall 888-506-7670Email iconEmail Study Center

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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