A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies

Last updated: December 5, 2024
Sponsor: Century Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Neoplasms

Treatment

Lymphodepleting Chemotherapy

IL-2

CNTY-101

Clinical Study ID

NCT05336409
CNTY-101-111-01 (ELiPSE-1)
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin'sLymphoma (NHL).

  2. Must have met the following criteria for prior treatment:

  3. Participants with aggressive NHL must have received at least 2 lines ofsystemic therapy (if not intended for transplant, have already undergone or beunwilling or unable to undergo chimeric antigen receptor [CAR] T-cell therapyto be eligible), or at least 3 lines of systemic therapy. Previous therapy musthave included a CD20-targeted agent and an anthracycline or alkylator.

  4. Participants with follicular lymphoma (FL) must have received at least 2 linesof systemic therapy and have high-risk disease. Previous therapy must haveincluded a CD20-targeted agent and an alkylator.

  5. Participants with marginal zone lymphoma (MZL) must have received at least 2prior systemic therapies.

  6. Measurable disease on screening evaluations.

  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  8. Adequate organ function.

  9. Life expectancy of ≥12 weeks.

Exclusion

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: participantswith 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

Total Participants: 75
Treatment Group(s): 3
Primary Treatment: Lymphodepleting Chemotherapy
Phase: 1
Study Start date:
January 24, 2023
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • University of Southern California - Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of California San Diego, Moores Cancer Center

    San Diego, California 92093
    United States

    Active - Recruiting

  • Medstar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • University of Kentucky - Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Oncology Hematology Care, Inc-Kenwood

    Cincinnati, Ohio 45236
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • UT Southwestern

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Houston Methodist Research Institute

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.