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

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

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.

Study Overview

• Status: Terminated
• Conditions: Aggressive Non-Hodgkin Lymphoma; R/R CD19-Positive B-Cell Malignancies; Indolent Non-Hodgkin Lymphoma
• Intervention / Treatment: Biological: CNTY-101; Biological: IL-2; Drug: Lymphodepleting Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California - Norris Comprehensive Cancer Center
    • San Diego, California, United States, 92093
      • University of California San Diego, Moores Cancer Center
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky - Markey Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati Medical Center
    • Cincinnati, Ohio, United States, 45236
      • Oncology Hematology Care, Inc-Kenwood
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity	Up to 28 days
Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR)	CRR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.	Up to 2 years
Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR)	ORR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.	Up to 2 years
Duration of Response (DOR)	DOR is defined as time from first response (CR or PR) to the first documentation of progressive disease (PD) or death.	Up to 2 years
Time to Treatment Response (TTR)	TTR is defined as time from first CNTY-101 infusion to the first documentation of response (CR or PR).	Day 1 up to 2 years
Progression-Free Survival (PFS)	PFS is defined as time from first CNTY-101 infusion to the first documentation of PD, or death from any cause, whichever occurs first	Day 1 up to 2 years
Overall Survival (OS)	OS is defined as time from CNTY-101 infusion to death.	Day 1 up to 2 years
Cmax: Maximum Observed Plasma Concentration for CNTY-101		Day 1 up to 2 years
Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101		Day 1 up to 2 years
t1/2: Terminal Disposition Phase Half-life for CNTY-101		Day 1 up to 2 years
AUC: Area under the Concentration-time Curve for CNTY-101		Day 1 up to 2 years
Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)		Day 1 up to 2 years
Percentage of Participants With Clinically Significant Laboratory Abnormalities		Day 1 up to 2 years
Time to Treatment Initiation	Time to treatment initiation is defined as the time from enrollment in the study to first CNTY-101 infusion.	Enrollment to first CNTY-101 infusion (up to approximately 2 weeks)

Collaborators and Investigators

• Sponsor: Century Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Lymphoma, Non-Hodgkin; Cell therapy; NK cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Cellular therapy; CNTY-101; Century Therapeutics; Induced pluripotent stem cells; CAR-NK
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Intercellular Signaling Peptides and Proteins; Cytokines; Interleukins; Lymphokines; Interleukin-2
• Other Study ID Numbers: CNTY-101-111-01 (ELiPSE-1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes