Overview

A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies (ELiPSE-1)

Status:
Not yet recruiting
Trial end date:
2027-08-01
Target enrollment:
0
Participant gender:
All
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 differentiation (CD)19-positive B-cell malignancies.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Century Therapeutics, Inc.
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.

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.