A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
- Conditions
- Aggressive Non-Hodgkin LymphomaIndolent Non-Hodgkin LymphomaR/R CD19-Positive B-Cell Malignancies
- Interventions
- Registration Number
- NCT05336409
- Lead Sponsor
- Century Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 28
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation: Schedule A CNTY-101 Lymphodepleting 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 A IL-2 Lymphodepleting 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 A Lymphodepleting Chemotherapy Lymphodepleting 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 CNTY-101 LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2. Dose Escalation: Schedule B IL-2 LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2. Dose Escalation: Schedule B Lymphodepleting Chemotherapy LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
- Primary Outcome Measures
Name Time Method Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC) Up to 28 days 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
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to 2 years DOR is defined as time from first response (CR or PR) to the first documentation of progressive disease (PD) or death.
Overall Survival (OS) Day 1 up to 2 years OS is defined as time from CNTY-101 infusion to death.
Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE) Day 1 up to 2 years Time to Treatment Initiation Enrollment to first CNTY-101 infusion (up to approximately 2 weeks) Time to treatment initiation is defined as the time from enrollment in the study to first CNTY-101 infusion.
Progression-Free Survival (PFS) Day 1 up to 2 years PFS is defined as time from first CNTY-101 infusion to the first documentation of PD, or death from any cause, whichever occurs first
Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR) Up to 2 years ORR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR) Up to 2 years CRR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
Cmax: Maximum Observed Plasma Concentration for CNTY-101 Day 1 up to 2 years Percentage of Participants With Clinically Significant Laboratory Abnormalities Day 1 up to 2 years Time to Treatment Response (TTR) Day 1 up to 2 years TTR is defined as time from first CNTY-101 infusion to the first documentation of response (CR or PR).
Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101 Day 1 up to 2 years t1/2: Terminal Disposition Phase Half-life for CNTY-101 Day 1 up to 2 years AUC: Area under the Concentration-time Curve for CNTY-101 Day 1 up to 2 years
Trial Locations
- Locations (16)
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
University of Southern California - Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
University of California San Diego, Moores Cancer Center
🇺🇸San Diego, California, United States
Medstar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
University of Kentucky - Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care, Inc-Kenwood
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States