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

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ClinicalTrials.gov Identifier: NCT05336409
Recruitment Status : Recruiting
First Posted : April 20, 2022
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Century Therapeutics, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
R/R CD19-Positive B-Cell Malignancies Indolent Non-Hodgkin Lymphoma Aggressive Non-Hodgkin Lymphoma Biological: CNTY-101 Biological: IL-2 Drug: Lymphodepleting Chemotherapy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 24, 2023
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC) [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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

  6. Overall Survival (OS) [ Time Frame: Day 1 up to 2 years ]
    OS is defined as time from CNTY-101 infusion to death.

  7. Cmax: Maximum Observed Plasma Concentration for CNTY-101 [ Time Frame: Day 1 up to 2 years ]
  8. Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101 [ Time Frame: Day 1 up to 2 years ]
  9. t1/2: Terminal Disposition Phase Half-life for CNTY-101 [ Time Frame: Day 1 up to 2 years ]
  10. AUC: Area under the Concentration-time Curve for CNTY-101 [ Time Frame: Day 1 up to 2 years ]
  11. Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE) [ Time Frame: Day 1 up to 2 years ]
  12. Percentage of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: Day 1 up to 2 years ]
  13. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05336409


Contacts
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Contact: Nikolaus Trede 888-506-7670 ClinicalTeamCNTY@centurytx.com

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Dr. Matthew Ulrickson    480-256-6444      
United States, California
University of Southern California - Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Dr Yaghmour    323-865-3170      
University of California San Diego, Moores Cancer Center Recruiting
San Diego, California, United States, 92093
Contact: Benjamin Heyman    858-822-6100    bheyman@health.ucsd.edu   
United States, District of Columbia
Medstar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Dr. Renteria    202-444-0939    Anne.Renteria@medstar.net   
United States, Kentucky
University of Kentucky - Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Dr. Chaitanya Iragavarapu    859-257-4488    c.iragavarapu@uky.edu   
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Dr Mattour    313-916-1266      
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Dr Moyo    980-442-2301      
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Dr Latif    513-584-7824      
Oncology Hematology Care, Inc-Kenwood Recruiting
Cincinnati, Ohio, United States, 45236
Contact: Dr. James Essell    513-751-2273    james.essell@usoncology.com   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Dr. Olalekan Oluwole    615-875-0060    olalekan.oluwole@vumc.org   
United States, Texas
Houston Methodist Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Dr. Pingali    713-441-9948    spingali@houstonmethodist.org   
United States, Virginia
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
Contact: Dr. Scott Cross    757-466-8683    scott.cross@usoncology.com   
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Dr Patel    206-386-2301      
Sponsors and Collaborators
Century Therapeutics, Inc.
More Information
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Responsible Party: Century Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05336409    
Other Study ID Numbers: CNTY-101-111-01 (ELiPSE-1)
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Century Therapeutics, Inc.:
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Cellular therapy
Cell therapy
 CNTY-101
Century Therapeutics
Induced pluripotent stem cells
CAR-NK
NK cell
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases