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

Indolent Non-Hodgkin Lymphoma Clinical Trial

— ELiPSE-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336409
• Other study ID #: CNTY-101-111-01 (ELiPSE-1)
• Status: Recruiting
• Phase: Phase 1
• Start date: January 24, 2023
• Est. completion date: August 2027

Study information

• Verified date: May 2024
• Source: Century Therapeutics, Inc.
• Contact: Nikolaus Trede
• Phone: 888-506-7670
• Email: ClinicalTeamCNTY[@]centurytx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 2027
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aggressive Non-Hodgkin Lymphoma
• Indolent Non-Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Neoplasms

Intervention

Biological:
• CNTY-101
CNTY-101 cells for intravenous (IV) infusion
• IL-2
IL-2 subcutaneous (SQ) injection

Drug:
• Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Oncology Hematology Care, Inc-Kenwood	Cincinnati	Ohio
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Houston Methodist Research Institute	Houston	Texas
United States	University of Kentucky - Markey Cancer Center	Lexington	Kentucky
United States	University of Southern California - Norris Comprehensive Cancer Center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	University of California San Diego, Moores Cancer Center	San Diego	California
United States	Swedish Cancer Institute	Seattle	Washington
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Century Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity		Up to 28 days
Primary	Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)		Up to 28 days
Secondary	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.	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	Time to Treatment Response (TTR)	TTR is defined as time from first CNTY-101 infusion to the first documentation of response (CR or PR).	Day 1 up to 2 years
Secondary	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	Day 1 up to 2 years
Secondary	Overall Survival (OS)	OS is defined as time from CNTY-101 infusion to death.	Day 1 up to 2 years
Secondary	Cmax: Maximum Observed Plasma Concentration for CNTY-101		Day 1 up to 2 years
Secondary	Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101		Day 1 up to 2 years
Secondary	t1/2: Terminal Disposition Phase Half-life for CNTY-101		Day 1 up to 2 years
Secondary	AUC: Area under the Concentration-time Curve for CNTY-101		Day 1 up to 2 years
Secondary	Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)		Day 1 up to 2 years
Secondary	Percentage of Participants With Clinically Significant Laboratory Abnormalities		Day 1 up to 2 years
Secondary	Time to Treatment Initiation	Time to treatment initiation is defined as the time from enrollment in the study to first CNTY-101 infusion.	Enrollment to first CNTY-101 infusion (up to approximately 2 weeks)