Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

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.

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

Keywords

R/R CD19-Positive B-Cell Malignancies, Indolent Non-Hodgkin Lymphoma, Aggressive Non-Hodgkin Lymphoma, 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, Lymphoma, Neoplasms, Non-Hodgkin Lymphoma, Lymphodepleting Chemotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • University of California San Diego, Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • University of Southern California - Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Century Therapeutics, Inc.
ID
NCT05336409
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 75 study participants
Last Updated