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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation: Schedule A 		Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
  • Biological: CNTY-101
    CNTY-101 cells for intravenous (IV) infusion
  • Biological: IL-2
    IL-2 subcutaneous (SQ) injection
  • Drug: Lymphodepleting Chemotherapy
    LDC as prespecified in the protocol.
Experimental
Dose Escalation: Schedule B 		LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
  • Biological: CNTY-101
    CNTY-101 cells for intravenous (IV) infusion
  • Biological: IL-2
    IL-2 subcutaneous (SQ) injection
  • Drug: Lymphodepleting Chemotherapy
    LDC as prespecified in the protocol.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky - Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Dr. Chaitanya Iragavarapu
859-257-4488
c.iragavarapu@uky.edu

More Details

NCT ID
NCT05336409
Status
Recruiting
Sponsor
Century Therapeutics, Inc.

Study Contact

Nikolaus Trede
888-506-7670
ClinicalTeamCNTY@centurytx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.