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R/R CD19-Positive B-Cell MalignanciesPhase 1ELiPSE-1NCT05336409

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

A Phase 1 study testing CNTY-101, IL-2 and Lymphodepleting Chemotherapy in people with R/R CD19-Positive B-Cell Malignancies and Indolent Non-Hodgkin Lymphoma, run by Century Therapeutics, Inc. at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CNTY-101, IL-2 and Lymphodepleting Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
16 sitesUnited States
Study dates
24 Jan 2023to 1 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).
  • Must have met the following criteria for prior treatment:
  • 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.
  • 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.
  • Participants with marginal zone lymphoma (MZL) must have received at least 2 prior systemic therapies.
  • Measurable disease on screening evaluations.
Show all 9Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.
  • Life expectancy of ≥12 weeks.

Who cannot join

  • Any condition that confounds the ability to interpret data from the study.
  • Central nervous system (CNS)-only involvement by malignancy. (Note: participants with secondary CNS involvement are allowed.)
  • Prior allogeneic stem cell transplant.
  • Presence of clinically significant CNS pathology.
  • Other comorbid conditions defined in the protocol.
  • Use of prohibited medications within the washout period defined in the protocol.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45229

  • Oncology Hematology Care, Inc-Kenwood

    Cincinnati, Ohio, 45236

  • UT Southwestern

    Dallas, Texas, 75390

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Corewell Health

    Grand Rapids, Michigan, 49503

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • University of Kentucky - Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Southern California - Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • University of California San Diego, Moores Cancer Center

    San Diego, California, 92093

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

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

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.

Being tested
CNTY-101, IL-2, Lymphodepleting Chemotherapy
Keywords
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
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CNTY-101Biological

    CNTY-101 cells for intravenous (IV) infusion

  • IL-2Biological

    IL-2 subcutaneous (SQ) injection

  • Lymphodepleting ChemotherapyDrug

    LDC as prespecified in the protocol.

Study groups in NCT05336409
Study groupRoleWhat they receive
Dose Escalation: Schedule AExperimentalLymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
Receives: Biological: CNTY-101; Biological: IL-2; Drug: Lymphodepleting Chemotherapy
Dose Escalation: Schedule BExperimentalLDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
Receives: Biological: CNTY-101; Biological: IL-2; Drug: Lymphodepleting Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity

    Measured: Up to 28 days

  2. Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)

    Measured: Up to 28 days

Secondary outcomes (13)

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

  3. 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.

    Measured: Up to 2 years

  4. Time to Treatment Response (TTR)

    TTR is defined as time from first CNTY-101 infusion to the first documentation of response (CR or PR).

    Measured: Day 1 up to 2 years

  5. 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

    Measured: Day 1 up to 2 years

  6. Overall Survival (OS)

    OS is defined as time from CNTY-101 infusion to death.

    Measured: Day 1 up to 2 years

  7. Cmax: Maximum Observed Plasma Concentration for CNTY-101

    Measured: Day 1 up to 2 years

  8. Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101

    Measured: Day 1 up to 2 years

  9. t1/2: Terminal Disposition Phase Half-life for CNTY-101

    Measured: Day 1 up to 2 years

  10. AUC: Area under the Concentration-time Curve for CNTY-101

    Measured: Day 1 up to 2 years

  11. Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)

    Measured: Day 1 up to 2 years

  12. Percentage of Participants With Clinically Significant Laboratory Abnormalities

    Measured: Day 1 up to 2 years

  13. Time to Treatment Initiation

    Time to treatment initiation is defined as the time from enrollment in the study to first CNTY-101 infusion.

    Measured: Enrollment to first CNTY-101 infusion (up to approximately 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start24 Jan 2023
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Why it stopped: Strategic decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05336409
Sponsor's protocol ID
CNTY-101-111-01 (ELiPSE-1)
Acronym
ELiPSE-1
Status last verified
Dec 2025
First submitted
8 Apr 2022
Last updated
18 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CNTY-101, IL-2 and Lymphodepleting Chemotherapy in people with R/R CD19-Positive B-Cell Malignancies and Indolent Non-Hodgkin Lymphoma, run by Century Therapeutics, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05336409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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