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.
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
- Conditions the study is for
- R/R CD19-Positive B-Cell Malignancies, Indolent Non-Hodgkin Lymphoma, Aggressive Non-Hodgkin Lymphoma
- 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.
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- 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
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.
- Conditions
- R/R CD19-Positive B-Cell Malignancies, Indolent Non-Hodgkin Lymphoma, Aggressive Non-Hodgkin Lymphoma
- 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 group | Role | What they receive |
|---|---|---|
| Dose Escalation: Schedule A | Experimental | Lymphodepleting 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 B | Experimental | LDC 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.
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
Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)
Measured: Up to 28 days
Secondary outcomes (13)
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
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
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
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
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
Overall Survival (OS)
OS is defined as time from CNTY-101 infusion to death.
Measured: Day 1 up to 2 years
Cmax: Maximum Observed Plasma Concentration for CNTY-101
Measured: Day 1 up to 2 years
Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101
Measured: Day 1 up to 2 years
t1/2: Terminal Disposition Phase Half-life for CNTY-101
Measured: Day 1 up to 2 years
AUC: Area under the Concentration-time Curve for CNTY-101
Measured: Day 1 up to 2 years
Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)
Measured: Day 1 up to 2 years
Percentage of Participants With Clinically Significant Laboratory Abnormalities
Measured: Day 1 up to 2 years
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.
- First posted20 Apr 2022
- Study start24 Jan 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Why it stopped: Strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for R/R CD19-Positive B-Cell MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Century Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05336409
- Acronym / sponsor ID
- ELiPSE-1 / CNTY-101-111-01 (ELiPSE-1)
- Conditions
- R/R CD19-Positive B-Cell Malignancies, Indolent Non-Hodgkin Lymphoma, Aggressive Non-Hodgkin Lymphoma
- Keywords
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Cellular therapy, Cell therapy, CNTY-101, Century Therapeutics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Century Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: Schedule A | Experimental | Biological: CNTY-101, Biological: IL-2, Drug: Lymphodepleting ChemotherapyLymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2). |
| Dose Escalation: Schedule B | Experimental | Biological: CNTY-101, Biological: IL-2, Drug: Lymphodepleting ChemotherapyLDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Measurable disease on screening evaluations.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNTY-101CNTY-101 cells for intravenous (IV) infusion | Biological | Dose Escalation: Schedule A, Dose Escalation: Schedule B |
| IL-2IL-2 subcutaneous (SQ) injection | Biological | Dose Escalation: Schedule A, Dose Escalation: Schedule B |
| Lymphodepleting ChemotherapyLDC as prespecified in the protocol. | Drug | Dose Escalation: Schedule A, Dose Escalation: Schedule B |
Primary outcome
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
Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)
Time frame: Up to 28 days
13 secondary outcomes
Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR)
Time frame: 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
Duration of Response (DOR)
Time frame: Up to 2 years
Time to Treatment Response (TTR)
Time frame: Day 1 up to 2 years
Progression-Free Survival (PFS)
Time frame: Day 1 up to 2 years
Overall Survival (OS)
Time frame: Day 1 up to 2 years
Cmax: Maximum Observed Plasma Concentration for CNTY-101
Time frame: 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
t1/2: Terminal Disposition Phase Half-life for CNTY-101
Time frame: Day 1 up to 2 years
AUC: Area under the Concentration-time Curve for CNTY-101
Time frame: 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
Percentage of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Day 1 up to 2 years
Time to Treatment Initiation
Time frame: Enrollment to first CNTY-101 infusion (up to approximately 2 weeks)
Results and safety
The study was stopped early (reason given: Strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 7 Nov 2026.