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

January 8, 2024 updated by: Century Therapeutics, Inc.

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California - Norris Comprehensive Cancer Center
        • Contact:
          • Dr Yaghmour
          • Phone Number: 323-865-3170
      • San Diego, California, United States, 92093
        • Recruiting
        • University of California San Diego, Moores Cancer Center
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky - Markey Cancer Center
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
          • Dr Mattour
          • Phone Number: 313-916-1266
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
        • Contact:
          • Dr Moyo
          • Phone Number: 980-442-2301
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
          • Dr Latif
          • Phone Number: 513-584-7824
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Oncology Hematology Care, Inc-Kenwood
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
    • Virginia
      • Norfolk, Virginia, United States, 23502
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute
        • Contact:
          • Dr Patel
          • Phone Number: 206-386-2301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 28 days
Up to 28 days
Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)
Time Frame: Up to 28 days
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)
Time Frame: Up to 2 years
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)
Time Frame: Up to 2 years
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)
Time Frame: Up to 2 years
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)
Time Frame: Day 1 up to 2 years
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)
Time Frame: Day 1 up to 2 years
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)
Time Frame: Day 1 up to 2 years
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
Time Frame: Day 1 up to 2 years
Day 1 up to 2 years
Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101
Time Frame: Day 1 up to 2 years
Day 1 up to 2 years
t1/2: Terminal Disposition Phase Half-life for CNTY-101
Time Frame: Day 1 up to 2 years
Day 1 up to 2 years
AUC: Area under the Concentration-time Curve for CNTY-101
Time Frame: Day 1 up to 2 years
Day 1 up to 2 years
Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)
Time Frame: Day 1 up to 2 years
Day 1 up to 2 years
Percentage of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Day 1 up to 2 years
Day 1 up to 2 years
Time to Treatment Initiation
Time Frame: Enrollment to first CNTY-101 infusion (up to approximately 2 weeks)
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

This is where you will find people and organizations involved with this study.

Sponsor

Century Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2027

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 (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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