Back to resultsA Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies (ELiPSE-1)
Primary Purpose
R/R CD19-Positive B-Cell Malignancies, Indolent Non-Hodgkin Lymphoma, Aggressive Non-Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CNTY-101
IL-2
Lymphodepleting Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for R/R CD19-Positive B-Cell Malignancies focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
- Life expectancy of ≥12 weeks.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Southern California - Norris Comprehensive Cancer CenterRecruiting
- Medstar Georgetown University HospitalRecruiting
- Henry Ford HospitalRecruiting
- Levine Cancer InstituteRecruiting
- University of Cincinnati Medical CenterRecruiting
- Oncology Hematology Care, Inc-KenwoodRecruiting
- Vanderbilt University Medical CenterRecruiting
- Houston Methodist Research InstituteRecruiting
- Virginia Oncology AssociatesRecruiting
- Swedish Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose Escalation: Schedule A
Dose Escalation: Schedule B
Arm Description
Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity
Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)
Secondary Outcome Measures
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.
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.
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.
Time to Treatment Response (TTR)
TTR is defined as time from first CNTY-101 infusion to the first documentation of response (CR or PR).
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
Overall Survival (OS)
OS is defined as time from CNTY-101 infusion to death.
Cmax: Maximum Observed Plasma Concentration for CNTY-101
Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101
t1/2: Terminal Disposition Phase Half-life for CNTY-101
AUC: Area under the Concentration-time Curve for CNTY-101
Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)
Percentage of Participants With Clinically Significant Laboratory Abnormalities
Time to Treatment Initiation
Time to treatment initiation is defined as the time from enrollment in the study to first CNTY-101 infusion.
Full Information
NCT ID
NCT05336409
First Posted
April 8, 2022
Last Updated
October 4, 2023
Sponsor
Century Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05336409
Brief Title
A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Century Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Induced pluripotent stem cells, CAR-NK, NK cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation: Schedule A
Arm Type
Experimental
Arm Description
Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
Arm Title
Dose Escalation: Schedule B
Arm Type
Experimental
Arm Description
LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
Intervention Type
Biological
Intervention Name(s)
CNTY-101
Intervention Description
CNTY-101 cells for intravenous (IV) infusion
Intervention Type
Biological
Intervention Name(s)
IL-2
Intervention Description
IL-2 subcutaneous (SQ) injection
Intervention Type
Drug
Intervention Name(s)
Lymphodepleting Chemotherapy
Intervention Description
LDC as prespecified in the protocol.
Primary Outcome Measure Information:
Title
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
Title
Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR)
Description
CRR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
Time Frame
Up to 2 years
Title
Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR)
Description
ORR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
Time Frame
Up to 2 years
Title
Duration of Response (DOR)
Description
DOR is defined as time from first response (CR or PR) to the first documentation of progressive disease (PD) or death.
Time Frame
Up to 2 years
Title
Time to Treatment Response (TTR)
Description
TTR is defined as time from first CNTY-101 infusion to the first documentation of response (CR or PR).
Time Frame
Day 1 up to 2 years
Title
Progression-Free Survival (PFS)
Description
PFS is defined as time from first CNTY-101 infusion to the first documentation of PD, or death from any cause, whichever occurs first
Time Frame
Day 1 up to 2 years
Title
Overall Survival (OS)
Description
OS is defined as time from CNTY-101 infusion to death.
Time Frame
Day 1 up to 2 years
Title
Cmax: Maximum Observed Plasma Concentration for CNTY-101
Time Frame
Day 1 up to 2 years
Title
Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101
Time Frame
Day 1 up to 2 years
Title
t1/2: Terminal Disposition Phase Half-life for CNTY-101
Time Frame
Day 1 up to 2 years
Title
AUC: Area under the Concentration-time Curve for CNTY-101
Time Frame
Day 1 up to 2 years
Title
Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)
Time Frame
Day 1 up to 2 years
Title
Percentage of Participants With Clinically Significant Laboratory Abnormalities
Time Frame
Day 1 up to 2 years
Title
Time to Treatment Initiation
Description
Time to treatment initiation is defined as the time from enrollment in the study to first CNTY-101 infusion.
Time Frame
Enrollment to first CNTY-101 infusion (up to approximately 2 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function.
Life expectancy of ≥12 weeks.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikolaus Trede
Phone
888-506-7670
Email
ClinicalTeamCNTY@centurytx.com
Facility Information:
Facility Name
University of Southern California - Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Yaghmour
Phone
323-865-3170
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Renteria
Phone
202-444-0939
Email
Anne.Renteria@medstar.net
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Mattour
Phone
313-916-1266
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Moyo
Phone
980-442-2301
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Latif
Phone
513-584-7824
Facility Name
Oncology Hematology Care, Inc-Kenwood
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. James Essell
Phone
513-751-2273
Email
james.essell@usoncology.com
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Olalekan Oluwole
Phone
615-875-0060
Email
olalekan.oluwole@vumc.org
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Pingali
Phone
713-441-9948
Email
spingali@houstonmethodist.org
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Scott Cross
Phone
757-466-8683
Email
scott.cross@usoncology.com
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Patel
Phone
206-386-2301
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
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