Clinical trial NCT05336409: A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
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
Induced pluripotent stem cells
CAR-NK
NK cell
Lead sponsor: Century Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity
timeFrame: Up to 28 days
measure: Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)
timeFrame: Up to 28 days
Secondary outcomes:
measure: Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR)
timeFrame: Up to 2 years
measure: Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR)
timeFrame: Up to 2 years
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Time to Treatment Response (TTR)
timeFrame: Day 1 up to 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Day 1 up to 2 years
measure: Overall Survival (OS)
timeFrame: Day 1 up to 2 years
measure: Cmax: Maximum Observed Plasma Concentration for CNTY-101
timeFrame: Day 1 up to 2 years
measure: Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101
timeFrame: Day 1 up to 2 years
measure: t1/2: Terminal Disposition Phase Half-life for CNTY-101
timeFrame: Day 1 up to 2 years
measure: AUC: Area under the Concentration-time Curve for CNTY-101
timeFrame: Day 1 up to 2 years
measure: Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)
timeFrame: Day 1 up to 2 years
measure: Percentage of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Day 1 up to 2 years
measure: Time to Treatment Initiation
timeFrame: Enrollment to first CNTY-101 infusion (up to approximately 2 weeks)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California - Norris Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: University of California San Diego, Moores Cancer Center
state: California
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Lexington
country: United States
facility: University of Kentucky - Markey Cancer Center
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc-Kenwood
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
References: